The Medical Devices Regulations 2002

• Citation: S.I. 2002/618
• Sections: 171

A45 Meaning of approved body and UK notified body

(1) An approved body is a conformity assessment body which—

(a) has been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); or

(b) immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation.

(2) In this regulation—

“UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”.

Section 1 Citation and commencement

These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.

Section 1A Schedules

Schedules 2 and 2A have effect.

Section 1ZA Expiry of certain provisions in these Regulations

(1) Subject to paragraph (3), regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028.

(2) Subject to paragraph (3), regulations 19C, 44ZA and 44ZB cease to have effect at 23:59 on 30 June 2030.

(3) The following cease to have effect at 23:59 on 30 June 2023—

(a) regulation 19B(4), (5), (8) and (9);

(b) regulation 19C(8) and (9);

(c) regulation 30A(4) to (7);

(d) regulation 44ZA(4) and (5);

(e) regulation 44ZB(4) and (5).

Section 2 Interpretation

(1) ... In these Regulations ...—

...

“active implantable medical device” means a medical device which—

relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and

is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced,

even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product;

...

“approved body” is to be construed in accordance with regulation A45;

...

...

“CE marking” means a conformity marking consisting of the initials “CE”;

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“clinical data” means the safety or performance information that is generated from the use of a device, derived from—

clinical investigations of the device concerned; or

clinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; or

published or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

“coronavirus test device” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

“designated standard ” has the meaning given in regulation 3A;

“device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises;

“ Directive 90/385 ” means Council Directive 90/385/ EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices as it had effect immediately before IP completion day ;

“ Directive 93/42 ” means Council Directive 93/42/ EEC of 14 June 1993 concerning medical devices as it had effect immediately before IP completion day ;

“ Directive 98/79 ” means Directive 98/79/ EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices as it had effect immediately before IP completion day ;

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“ Directive 2003/12 ” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;

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“Directive 2005/50” means Commission Directive 2005/50/ EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/ EEC concerning medical devices;

“Directive 2007/47” means Directive 2007/47/ EC of the European Parliament and of the Council amending Council Directive 90/385/ EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/ EEC concerning medical devices and Directive 98/8/ EC concerning the placing of biocidal products on the market;

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“ ... CAB” shall be construed in accordance with regulation 48(1);

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...

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“hazard” means a potential source of injury or damage to health;

“hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws, wedges, plates and instruments);

“intended for clinical investigation” means—

intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; or

intended for use by any other person in Great Britain who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;

“intended purpose” means—

in relation to an active implantable medical device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it;

in relation to any other medical device, the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;

“ in vitro diagnostic medical device” means a medical device which—

is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

concerning a physiological or pathological state,

concerning a congenital abnormality,

to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

to monitor therapeutic measures,

and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination;

“machinery” has the meaning given to it by regulation 4 of the Supply of Machinery (Safety) Regulations 2008 ;

“manufacturer” means—

the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or

any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—

is intended by the manufacturer to be used for human beings for the purpose of-

diagnosis, prevention, monitoring, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

investigation, replacement or modification of the anatomy or of a physiological process, or

control of conception; and

does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,

and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

“the Medical Devices Directives” means Directive 90/385, Directive 93/42, both read with Regulation ( EU ) No 207/2012 and Regulation ( EU ) No 722/2012 and Directive 98/79;

...

“medicinal product” has the meaning given in regulation 2(1) of the Human Medicines Regulations 2012 ;

“ mutual recognition agreement ” means an agreement that—

is between the United Kingdom and a country listed in Schedule 2, and

covers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of conformity assessment procedures undertaken by the each other's designated bodies;

...

...

...

“placing on the market” means, in relation to a medical device, the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on the Great Britain market and related expressions must be construed accordingly ;

“putting into service” means—

in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;

in relation to any other medical device, the first making available of the device in Great Britain to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

“Regulation ( EU ) No 207/2012” means Commission Regulation ( EU ) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices; (as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act)

“Regulation (EU) No 722/2012”—

in Part 4A, has the meaning given in regulation 44ZC;

in all other Parts means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (as retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act);

“ Regulation (EU) 2017/745 ” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC , Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ;

“ Regulation (EU) 2017/746 ” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU ;

“ Regulation (EU) 2022/1107 ” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council;

“relevant essential requirements”—

in Part 4A, has the meaning given in regulation 44ZC;

in all other Parts, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;

“specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;

“stable derivatives device” means a medical device that contains human blood, blood products, plasma or blood cells of human origin, and which incorporates, as an integral part, a substance which—

if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of regulation 2(2) of the Human Medicines Regulations 2012 ; and

is liable to act upon the human body with action ancillary to that of the device;

“ statistical review ” means a review of the statistical sections of the written notice which a manufacturer or their UK responsible person submits to the Secretary of State pursuant to regulation 16(1) or 29(1) in respect of an intended clinical investigation of a relevant device;

“supply”, in relation to a medical device, means—

the supply of, or the offer or agreement to supply, the device; or

the exposure or possession for supply of the device;

“ third country conformity assessment body ” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations;

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“UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008 ;

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“ UK responsible person ” means a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations ; and

“ working day ” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971.

(1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.

(1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation ( EU ) No 207/2012.

(2) In these Regulations, unless the context otherwise requires, a reference—

(a) to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;

(b) in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

(c) in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

Section 2A Medical devices which are qualifying Northern Ireland goods

(1) Subject to paragraph (1A), notwithstanding the effect of regulations 19B, 19C, 30A, 44ZA and 44ZB and the expiry of the period during which those regulations apply by virtue of regulation 1ZA, any medical device—

(a) which meets the requirements of—

(i) these Regulations as they apply in Northern Ireland;

(ii) Regulation (EU) 2017/745 ; or

(iii) Regulation (EU) 2017/746 ; and

(b) which is a qualifying Northern Ireland good,

may be placed on the Great Britain market as if it meets the requirements of these Regulations as they apply in Great Britain.

(1A) Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—

(a) regulation 34A (approval requirement for coronavirus test devices); or

(b) the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107 .

(2) In this regulation,

(a) “qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

(b) “Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC , Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC .

Section 3 Scope of these Regulations

These Regulations shall not apply to—

(a) medicinal products governed by the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma ...);

(b) human blood, human blood products, plasma or blood cells of human origin;

(c) devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for —

(i) stable derivatives devices,

(ii) active implantable medical devices and accessories to such devices, and

(iii) in vitro diagnostic medical devices and accessories to such devices, ;

(d) transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin , except for ..., in vitro diagnostic medical devices and accessories to such devices save where medicinal products are incorporated as ancillary to the device ;

(e) transplants or tissues or cells of animal origin, unless—

(i) a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

(ii) a product is ... an in vitro diagnostic medical device, or an accessory to such a device;

(f) cosmetic products governed by Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; or

(g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 3A Designated standard

(1) In Parts II, III and IV of these Regulations, a “ designated standard ” means—

(a) a technical specification which is—

(i) adopted by a recognised standardisation body or an international standardising body , for repeated or continuous application with which compliance is not compulsory; and

(ii) designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; or

(b) a monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.

(2) For the purposes of paragraph (1), a “ technical specification ” means a document which prescribes technical requirements to be fulfilled by a device, process, service or system (“the product”) and which lays down—

(a) the characteristics required of a product, including levels of quality, performance, interoperability, environmental protection, health and safety and dimensions;

(b) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(c) the production methods and processes relating to the product, where these have an effect on its characteristics.

(3) For the purposes of this regulation a “ recognised standardisation body ” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (CENELEC);

(c) the British Standards Institute (BSI).

(3A) In this regulation “ international standardising body ” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a standard in relation to a technical specification which has been adopted by BSI, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant.

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation—

(a) a reference to a “ device ” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply;

(b) a reference to “ the European Pharmacopoeia ” is a reference to the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.

Section 3B Confidentiality

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Section 3ZA Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

(1) Subject to paragraph (2), Parts 2 to 7 only apply in Northern Ireland for the purpose of regulating qualifying devices.

(2) The following provisions continue to apply in Northern Ireland in accordance with this paragraph ...—

(a) for the purposes of the registration of medical devices (whether or not they are qualifying devices) and persons placing medical devices on the market in Northern Ireland—

(i) regulation 19 (registration of persons placing general medical devices on the market),

(ii) regulation 21B (registration of persons placing active implantable medical devices on the market),

(iii) regulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation), and

(iv) regulation 53 (fees in connection with the registration of devices and changes to registration details),

only apply until the date which is 24 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745 ;

(aa) regulations 34A to 34D, 38A to 38C, 39A, 56A, 59 and 61 continue to apply in relation to coronavirus test devices whether or not they are qualifying devices;

(b) Parts 5 to 7 also apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.

(3) For the purposes of this regulation , a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745 or Article 110 of Regulation (EU) 2017/746 —

(a) it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746 ; and

(b) it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2 ... to 7.

Section 4 Transitional provisions

(1) Part II shall not be applied before 1st July 2004 in respect of a device which has been subjected to EEC pattern approval before 1st January 1995 in accordance with the Clinical Thermometers (EEC Requirements) Regulations 1993 .

(2) Part II shall not be applied—

(a) before 10th January 2007 in respect of a stable derivatives device placed on the market without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002; or

(b) before 10th January 2009 in respect of a stable derivatives device put into service without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002.

(3) Part IV shall not be applied before 7th December 2003 in respect of a device placed on the market which is—

(a) an in vitro diagnostic medical device without a CE marking; or

(b) a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 7th December 1998.

(4) Part IV shall not be applied before 7th December 2005 in respect of a device put into service which is—

(a) an in vitro diagnostic medical device without a CE marking; or

(b) a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is put into service as in force on 7th December 1998.

(5) Regulation 13(4) shall not be applied before 1st March 2004 in respect of breast implants which—

(a) bore a CE marking before 1st September 2003; and

(b) satisfy the requirements in respect of relevant devices falling within Class IIb set out in regulation 13(3).

(6) Regulation 19A shall not be applied before 1st October 2004 in respect of a device placed on the market before 1st April 2004.

Section 4A Transitional provisions for hip, knee and shoulder replacements

(1) This regulation applies to hip, knee or shoulder replacements.

(2) Regulation 13(4) shall not apply in respect of a replacement—

(a) whose manufacturer or his authorised representative has before 1st September 2007—

(i) fulfilled the applicable obligations imposed by Annex II , excluding Section 4 of that Annex,

(ii) declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

(iii) ensured that the device meets the provisions of Directive 93/42 which apply to it; and

(b) in respect of which an examination under Section 4 of Annex II has been carried out and an EC design-examination certificate under that Section has been issued before 1st September 2009.

(3) Regulation 13(4) shall not apply before 1st September 2009 in respect of a replacement—

(a) whose manufacturer or his authorised representative has—

(i) fulfilled the applicable obligations imposed by Annex II , excluding Section 4 of that Annex,

(ii) declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

(iii) ensured that the device meets the provisions of Directive 93/42 which apply to it; and

(b) which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex II before 1st September 2007.

(4) Regulation 13(4) shall not apply before 1st September 2010 in respect of replacement—

(a) whose manufacturer or his authorised representative has—

(i) fulfilled the applicable obligations imposed by Annex III together with Annex VI ,

(ii) declared, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it, and

(iii) ensured that the device meets the provisions of Directive 93/42 which apply to it; and

(b) which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex VI before 1st September 2007.

(5) Regulation 13(4) shall not apply in respect of a replacement which—

(a) satisfies the conditions set out in paragraph (4)(a) and (b);

(b) has been placed on the market before 1st September 2010; and

(b) is put into service on or after that date.

Section 4D Revocations, transitional and saving provisions in respect of the new national registration requirements

(1) Regulation 19 is revoked on the day that is 4 months after IP completion day (which is when regulation 7A comes into force).

(2) Regulation 7A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—

(a) that is a relevant device for the purposes of Part II; and

(b) that is classified as belonging to—

(i) Class IIa, as referred to in regulation 7, or

(ii) Class IIb, as referred to in regulation 7, and is also a Group A device (within the meaning given in regulation 52(1)).

(3) Regulation 7A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory—

(a) that is a relevant device for the purposes of Part II; and

(b) that is classified as belonging to Class I, as referred to in regulation 7.

(4) Where regulation 7A does not apply in respect of a device or accessory by virtue of paragraph (2) or (3), regulation 19 continues to have effect after its revocation in respect of that device or accessory.

(6) Regulation 30(3) is revoked on the day that is 4 months after IP completion day (which is when regulation 21A comes into force).

(8) Regulation 44 is revoked on the day that is 4 months after IP completion day (which is when regulation 33A comes into force).

(9) Regulation 33A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—

(a) that is a relevant device for the purposes of Part IV, or

(b) that is—

(i) referred to in List B, mentioned in regulation 40(4), or

(ii) a device for self-testing (as defined in relation 32(1)).

(10) Regulation 33A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory that is a relevant device for the purposes of Part IV which follows the procedure in regulation 40(1).

(11) Where regulation 33A does not apply in respect of a device or accessory by virtue of paragraph (9), regulation 44 continues to have effect after its revocation in respect of that device or accessory.

Section 4H Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date

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Section 4I Revocation of Commission Decision 2010/227

Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) is revoked.

Section 4J Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025

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Section 4K Revocation of Regulation (EU) No 722/2012 on 26th May 2025

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Section 4L Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date

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Section 4M Revocation of Regulation (EU) No 2017/2185 and saving provision

(1) Insofar as it is retained EU law, Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (“Regulation (EU) No 2017/2185”) is revoked.

Section 4N The classification criteria in Directives 2003/12 and 2005/50

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Section 4O Revocation of Regulation (EU) 2017/745

(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC , Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“ the Medical Devices Regulation ”) (insofar as it is retained EU law) is revoked.

Section 4P Revocation of Regulation (EU) 2017/746

(1) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“ the in vitro diagnostic medical devices Regulation ”) (insofar as it is retained EU law) is revoked.

Section 4T References in other legislation to Directives 90/385, 93/42 and 98/79

(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In regulation 10(5) of the Medicines (Products for Human Use) (Fees) Regulations 2016 (fee for advice for other purposes)—

(a) the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to having the meaning given in regulation 2; and

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) the reference to the expression “ Directive 93/42/EEC ” is to be construed, to the extent necessary for the practical application of that expression, as a reference also or instead to Part II of the Medical Devices Regulations 2002;

(d) the references to “paragraph 4.3 of Annex II to Directive 93/42/EEC ” and “paragraph 5 of Annex III to Directive 93/42/EEC ” are to be construed, to the extent necessary for the practical application of those provisions, as references also or instead to those paragraphs and those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.

(3) In Schedule 1 to the Pressure Equipment (Safety) Regulations 2016 (excluded pressure equipment and assemblies), the reference in paragraph 1(f)(iv) to not being covered by Directive 93/42 is to be construed, to the extent necessary for the practical application of that provision, as a reference also or instead to not being covered by Part II.

(4) In regulation 2 of the Waste Electrical and Electronic Equipment Regulations 2013 (interpretation)—

(a) the reference to the expression “active implantable medical device” having the meaning given in Article 1(2)(c) of Directive 90/385 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to it having the meaning given in regulation 2 ...;

(b) the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference to it also or instead having the meaning given to it in regulation 2;

(c) the reference to the expression “accessory” having the meaning given in Article 1(2)(b) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 5;

(d) the reference to the expression “in vitro diagnostic medical device” having the meaning given in Article 1(2)(b) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as having the meaning given to it in regulation 2;

(e) the reference to the expression “accessory” having the meaning given in Article 1(2)(c) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 32.

(5) These Regulations are an enactment implementing a relevant Community Directive for the purposes of regulation 4 of the Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 (provision of personal protective equipment).

(6) These Regulations are also an enactment implementing a relevant Community Directive for the purposes of regulation 4(5)(a) of the Personal Protective Equipment at Work Regulations 1992 (provision of personal protective equipment).

Section 5 Interpretation of Part II

(1) In this Part ...—

“accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;

“custom-made device” means a relevant device that is—

manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; and

intended for the sole use of a particular patient,

but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;

“relevant device” shall be construed in accordance with regulation 6;

“single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and

“system or procedure pack” has the same meaning as in article 12 of Directive 93/42.

(2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.

Section 6 Scope of Part II

The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—

(a) active implantable medical devices and accessories to such devices; and

(b) in vitro diagnostic medical devices and accessories to such devices; and

(c) devices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i) the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii) the manufacturer chooses to follow the set of arrangements in the other Directive.

Section 7 Classification of general medical devices

(1) For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50 .

(2) In the event of a dispute between a manufacturer and an approved body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50 .

Section 7A Registration of persons placing general medical devices on the market

(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a) is established in Great Britain; and

(b) has complied with paragraph (2).

(2) A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

(a) where—

(i) that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

(ii) that person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

(iii) that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

(b) that person supplies the Secretary of State with a description of the relevant device; and

(c) that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

(a) ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b) keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c) in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d) where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

(e) where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

(f) cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

(h) if the manufacturer acts contrary to its obligations under these Regulations—

(i) terminate the legal relationship with the manufacturer; and

(ii) inform the Secretary of State and, if applicable, the relevant approved body of that termination.

(4) In this regulation—

(a) the references to “technical documentation” are to be construed in accordance with Annex II, III or VII;

(b) the references to “declaration of conformity” are to be construed in accordance with Annexes II, IV, V, VI and VII.

Section 8 Essential requirements for general medical devices

(1) Subject to regulation 12, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) .

(2) Subject to regulation 12, no person shall supply a relevant device—

(a) if that supply is also a placing on the market or putting into service of that device; or

(b) in circumstances where that device has been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) .

(3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.

Section 9 Determining compliance of general medical devices with relevant essential requirements

(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.

(3) In the case of a relevant device which is being or has been put into service—

(a) the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and

(b) the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—

(i) such instructions are in English ...

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard , unless there are reasonable grounds for suspecting that it does not comply with that requirement.

(5) A custom-made device—

(a) in respect of which the conditions specified in Annex VIII are satisfied; and

(b) in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

(a) ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII ; and

(b) ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.

(6) Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or their UK responsible person , has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.

(7) A device intended for clinical investigation in respect of which—

(a) the conditions specified in Annex VIII are satisfied;

(b) notice has been given under regulation 16(1); and

(c) either—

(i) no notice has been given under regulation 16(4) within the period of 60 days there referred to, or

(ii) notice has been given under regulation 16(5),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(8) A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I ... that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.

(9) Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC and Directive 93/42, the relevant basic health and safety requirements of Regulation (EU) 2016/425 shall also be fulfilled.

Section 10 UK marking of general medical devices

(1) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a UK marking which—

(a) meets the requirements set out in Annex 2 of Regulation (EC) No 765/2008 ;

(b) is in a visible, legible and indelible form; and

(c) is accompanied by any relevant approved body or conformity assessment body identification number for that device.

(2) Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a UK marking which—

(a) meets the requirements set out in Annex 2 of Regulation (EC) No 765/2008 ;

(b) is in a visible, legible and indelible form; and

(c) is accompanied by any relevant approved body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008 , appears on—

(a) any sales packaging for that device; and

(b) the instructions for use for the device,

and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.

(4) Subject to regulations 12 and 14, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008 , appears on—

(a) any sales packaging for that device; and

(b) the instructions for use for the device,

and that UK marking is accompanied by any relevant approved body or conformity assessment body identification number for that device.

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a) a relevant device or its sterile pack;

(b) the instructions for use for a relevant device; or

(c) any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the UK marking or which reduces the visibility or the legibility of the UK marking .

(6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008 , the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

(a) as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

(b) as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).

Section 10A UK(NI) indication: general medical devices

(1) Where the CE marking referred to in regulation 10 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a) visibly, legibly and indelibly; and

(b) before a relevant device is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever such marking is affixed in accordance with regulation 13.

(3A) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.

(4) The UK(NI) indication must be affixed by the manufacturer.

(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.

Section 11 UK marking of general medical devices that come within the scope of this Part and other legislation

Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.

Section 12 Exemptions from regulations 8 and 10

(1) A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.

(2) Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—

(a) the system or procedure pack incorporates a medical device which does not bear a UK marking ; or

(b) the chosen combination of medical devices is not compatible in view of their original intended use.

(4) Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.

(5) Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a UK marking , where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

(6) Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.

(7) In paragraph (6), the Secretary of State, in determining whether another standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Section 13 Procedures for affixing a UK marking to general medical devices

(1) A relevant device falling within Class I may bear a UK marking only if its manufacturer or their UK responsible person —

(a) fulfils the applicable obligations imposed by Annex VII;

(b) declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of this Part which apply to it; and

(c) ensures that the device meets the provisions of this Part which apply to it.

(2) A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person —

(a) fulfils the applicable obligations imposed by—

(i) Annex II, excluding Section 4 of that Annex, or

(ii) Annex VII, together with Annex IV, V or VI;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and

(c) ensures that the device meets the provisions of this Part which apply to it.

(3) A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person —

(a) fulfils the applicable obligations imposed by—

(i) Annex II, excluding Section 4 of that Annex, or

(ii) Annex III, together with Annex IV, V or VI;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and

(c) ensures that the device meets the provisions of this Part which apply to it.

(4) A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person —

(a) fulfils the applicable obligations imposed by—

(i) Annex II, or

(ii) Annex III, together with Annex IV or V;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; ...

(c) ensures that the device meets the provisions of this Part which apply to it; and

(d) fulfils the obligations imposed by Regulation ( EU ) No 722/2012 (if applicable).

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 14 Procedures for systems and procedure packs, and for devices to be sterilised before use

(1) Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—

(a) the medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;

(b) the person who places or has placed it on the market has drawn up a declaration that—

(i) he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,

(ii) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and

(iii) his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,

and that declaration is true at the time it is made and continues to be true.

(2) Subject to paragraph (3), no person shall supply—

(a) a system or procedure pack which was sterilised before being placed on the market; or

(b) a relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,

(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).

(3) Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.

(4) The conditions referred to in paragraph (2) are that the person shall—

(a) follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; and

(b) if the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

(4A) The application of Annex II or IV and the intervention of the approved body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.

(5) Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—

(a) no person shall affix a UK marking to that device as a result of that procedure; and

(b) no person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

(6) The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.

Section 15 Procedures for custom-made general medical devices

No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or their UK responsible person —

(a) has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII , read with Regulation ( EU ) No 722/2012 ;

(b) has undertaken to keep available for the Secretary of State documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of Directive 93/42; and

(c) takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; ...

(d) keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) ; and

(e) ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.

Section 16 Procedures for general medical devices for clinical investigations

(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in Great Britain unless, before he does so, the manufacturer of the device or their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a) subject to paragraph (3), the statement required by Sections 1 and 2.2 of Annex VIII , read with Regulation ( EU ) No 722/2012 ; and

(b) an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.

(1A) A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

(a) obtain advice on regulatory requirements relating to an intended clinical investigation; or

(b) obtain a statistical review in relation to an intended clinical investigation.

(2) Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a UK marking otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was UK marked in accordance with regulation 13.

(3) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or their UK responsible person as soon as it becomes available.

(4) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(5) The Secretary of State may, in respect of notice in writing given by a manufacturer or their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or their UK responsible person —

(a) that the relevant device may be made available for the purposes of the intended investigation; or

(b) if the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(6) A written notice pursuant to paragraph (5) may—

(a) where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b) at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(7) Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—

(a) further clinical use of the relevant device in the investigation is prohibited; and

(b) no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(8) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or their UK responsible person , shall—

(a) take all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;

(b) authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; and

(c) keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.

(9) The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—

(a) the manufacturer or their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); or

(b) the manufacturer or their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

(10) No person shall conduct a clinical investigation of a relevant device—

(a) otherwise than in accordance with Annex X; and

(b) otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or their UK responsible person shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.

(11) The manufacturer, or their single UK responsible person , shall—

(a) notify the Secretary of State of the end of the clinical investigation; and

(b) provide justification where premature termination has resulted.

Section 17 Manufacturers etc. and conformity assessment procedures for general medical devices

(1) A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in this Part shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2) A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with this Part at an intermediate stage of manufacture of the device.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 18 Approved bodies and the conformity assessment procedures for general medical devices

(1) An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a) take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device;

(b) take account of any relevant information relating to the characteristics and performance of that device, ...; and

(c) lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annex II to IV.

(2) Where an approved body takes a decision in accordance with Annex II , III , V or VI , they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3) Where an approved body and a manufacturer or the manufacturer’s UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or the manufacturer’s UK responsible person , extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 19 Registration of persons placing general medical devices on the market

(1) Paragraph (2) applies—

(a) in relation to relevant devices that are neither Class I devices nor custom-made devices, to—

(i) a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any general medical device of any class, other than a system or procedure pack which is not CE marked;

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii) a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv) a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

(b) in relation to Class I devices that are not custom-made devices , to—

(i) a manufacturer who places a device on the Northern Ireland market and has a registered place of business in Northern Ireland;

(ii) an authorised representative with a registered place of business in Northern Ireland;

(c) to a person with a registered place of business in Northern Ireland who sterilises before use any devices designed by their manufacturer to be sterilised before use.

(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

(a) inform the Secretary of State of their address and registered place of business;

(b) supply the Secretary of State with a description of each category of device concerned;

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) in the case of an authorised representative, supply the Secretary of State with—

(i) written evidence that they have been designated as an authorised representative;

(ii) details of the person who has so designated them; and

(iii) where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

(e) inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

(4) The obligations in paragraph (2) begin to apply—

(a) in the case of a device that is a Class I device and custom-made devices, on 1st January 2021;

(b) in the case of a device that is a Class III or IIb implantable device, on 1st May 2021;

(c) in the case of a device that is a Class IIa or Class IIb non-implantable device, on 1st September 2021.

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 19A Additional requirements relating to use of animal tissues

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 19B Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42

(1) In this regulation—

(a) “the Directive” means Directive 93/42 as it had effect on 25 May 2021 and any reference to an Article or Annex is a reference to that Article or Annex in the Directive ...;

(b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU law;

(c) “CE marking” means the CE marking required by Article 17 and shown in Annex XII;

(d) “harmonised standard” is to be construed in accordance with Article 5.

(2) Where paragraph (3) applies regulations 8, 9, 10(1) to (4), 11 and 13 are treated as being satisfied.

(3) Subject to paragraph (3A), this paragraph applies where, before placing a relevant device other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

(a) ensures—

(i) that the device meets the essential requirements set out in Annex I and, where applicable, Regulation 722/2012, which apply to it; or

(ii) that paragraph (10) and (11) apply;

(b) ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 11;

(ba) ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;

(c) ensures that the documentation required by the conformity assessment procedure is drawn up;

(d) ensures that the technical and other relevant documentation required by the relevant conformity assessment procedure is prepared in or translated into English;

(e) affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes II, III, IV, V, VI or VII;

(f) has drawn up before 26 May 2021 an EU declaration of conformity in accordance with Article 11; and

(g) ensures that the declaration of conformity is prepared in or translated into English.

(3A) Paragraph (3) only applies to a class I device under the Directive if—

(a) the conformity assessment procedure under Article 11 required the involvement of a notified body; or

(b) the conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).

(4) Where paragraph (5) applies, regulations 8 and 15 are treated as being satisfied.

(5) This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

(a) has drawn up a statement in English containing the information required by Section 1 and specified in Section 2.1 of Annex VIII, read with Regulation 722/2012;

(b) has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow an assessment of conformity of the device with the requirements of the Directive;

(c) undertakes to the Secretary of State—

(i) to comply with Section 3.1 of Annex VIII;

(ii) to keep all documentation required by Annex VIII available in accordance with Section 4 of Annex VIII; and

(iii) to pass the statement mentioned in subparagraph (a) on with the custom-made device so that it may be made available to the patient on request.

(6) Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.

(7) This paragraph applies where before a system or procedure pack is placed on the market, the manufacturer—

(a) has complied with Article 12(2);

(b) has complied with Article 12(3) and with the procedure in Annex II or V;

(ba) ensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;

(bb) ensures that the declarations required by Article 12 were drawn up before 26 May 2021;

(c) undertakes to keep the declarations required by Article 12 for the period specified in Article 12(4); ...

(d) ensures that the system or procedure pack is accompanied by the information referred to in point 13 of Annex I which must be in English; and

(e) ensures that the system or procedure pack does not contain a class I device under the Directive for which—

(i) the conformity assessment procedure under Article 11 did not require the involvement of a notified body; and

(ii) the conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).

(8) Where paragraph (9) applies, regulations 8 and 16 are treated as being satisfied.

(9) This paragraph applies where before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

(a) has provided the Secretary of State with the relevant written notice which must be in English in the form of the Statement required by Sections 1 and 2.2 of Annex VIII;

(b) undertakes to keep available the documentation referred to in Section 3.2 of Annex VIII for the period specified in Section 4 of that Annex; and

(c) has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of paragraph 3.1 of Annex VIII.

(10) Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4).

(11) This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

(12) For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

Section 19C Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745

(1) In this regulation—

(a) “the Regulation” means Regulation (EU) 2017/745, as it has effect in EU law, and any reference to an Article or an Annex is a reference to an Article or Annex of the Regulation;

(b) “CE marking” means the CE marking required by Article 20 and presented in Annex V;

(c) “harmonised standard” has the meaning given in Article 2(70);

(d) “sponsor” has the meaning given in Article 2(49).

(2) Where paragraph (3) applies, regulations 8, 10(1) to (4), 11, 13, 22, 23, 24 and 27 are treated as being satisfied.

(3) This paragraph applies where, before placing a relevant device within the meaning of Part II or Part III (as the case may be) other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—

(a) ensures—

(i) that the device meets the general safety and performance requirements in Annex I which apply to it; or

(ii) that paragraphs (10) and (11) apply;

(b) ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 52;

(ba) ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;

(c) ensures that the documentation required by the relevant conformity assessment procedure is drawn up;

(d) ensures that the technical documentation required by Annexes II and III and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;

(e) affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes IX, X or XI;

(f) draws up an EU declaration of conformity in accordance with Article 19;

(g) ensures that the declaration of conformity is prepared in or translated into English.

(4) Where paragraph (5) applies regulations 8 and 15 (or as the case may be) 22 and 28 are treated as being satisfied.

(5) This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—

(a) has drawn up a statement in English containing the information specified in Section 1 of Annex XIII;

(b) has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent national authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow assessment of the conformity of the device with the requirements of the Regulation; and

(c) undertakes to comply with Sections 3 (manufacturing), 4 (retention of information) and 5 (review of experience) of Annex XIII.

(6) Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.

(7) This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack—

(a) has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; and

(b) ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn.

(8) Where paragraph (9) applies, regulations 8 and 16(1) or (as the case may be) 22 and 29(1) are treated as being satisfied.

(9) This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—

(a) has provided the Secretary of State with the required notice in the form of the application required by Article 70 in English; and

(b) has provided the Secretary of State with an undertaking to keep available documentation contained in the application in accordance with Section 3 of Chapter III of Annex XV.

(10) Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4) or regulation 23(4) (as the case may be).

(11) This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.

(12) For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

Section 20 Interpretation of Part III

(1) In this Part ...—

“custom-made device” means an active implantable medical device that is—

manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and

intended to be used only for a particular patient; and

“relevant device” shall be construed in accordance with regulation 21.

(2) In this Part ..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.

Section 21 Scope of Part III

(1) The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, ...

(2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.

(3) Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 21A Registration of persons placing active implantable medical devices on the market

(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a) is established in Great Britain; and

(b) has complied with paragraph (2).

(2) A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

(a) where—

(i) that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

(ii) that person is the manufacturer of that device and is based outside the United Kingdom, and the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

(iii) that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

(b) that person supplies the Secretary of State with a description of the relevant device; and

(c) that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

(a) ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b) keep available to the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c) in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d) where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

(e) where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

(f) cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

(h) if the manufacturer acts contrary to its obligations under these Regulations—

(i) terminate the legal relationship with the manufacturer; and

(ii) inform the Secretary of State and, if applicable, the relevant approved body of that termination.

(4) In this regulation—

(a) the references to “technical documentation” are to be construed in accordance with Annex 2, 3 or 5;

(b) the references to “declaration of conformity” are to be construed in accordance with Annexes 2, 3 and 5.

Section 21B Registration of persons placing active implantable medical devices on the market

(1) Paragraph (2) applies—

(a) in relation to relevant devices other than custom-made devices, to—

(i) a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any relevant device;

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii) a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv) a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

(a) inform the Secretary of State of the address of their registered place of business; and

(b) supply the Secretary of State with a description of each category of device concerned;

(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) in the case of an authorised representative, supply the Secretary of State with—

(i) written evidence that they have been designated as an authorised representative;

(ii) details of the person who has so designated them; and

(iii) where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

(e) inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of the date specified in paragraph (4).

(4) The obligations in paragraph (2) begin to apply on 1st May 2021.

(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 21C Requirement to appoint a UK responsible person for active implantable medical devices

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 22 Essential requirements for active implantable medical devices

(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) .

(2) Subject to regulation 26, no person shall supply a relevant device—

(a) if that supply is also a placing on the market or putting into service of that device; or

(b) in circumstances where that device has also been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) .

Section 23 Determining compliance of active implantable medical devices with relevant essential requirements

(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) Any—

(a) determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

(b) evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

(3) In the case of a relevant device which is being or has been put into service—

(a) the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

(b) the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

(i) the instructions are in English ...

(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard , unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

(5) A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(6) A device intended for clinical investigation in respect of which—

(a) the conditions specified in Annex 7 are satisfied;

(b) notice has been given under regulation 29(1); and

(c) either—

(i) no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

(ii) notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.