Design and manufacture in accordance with essential safety requirements and sound engineering practice
(1) Before placing a category A vessel on the market, a manufacturer must ensure that the vessel has been designed and manufactured in accordance with the essential safety requirements. (2) Before placing a category B vessel on the market, a manufacturer must ensure that the vessel has been designed and manufactured in accordance with sound engineering practice .
Technical documentation and conformity assessment for category A vessels
Before placing a category A vessel on the market, a manufacturer must– (a) draw up the technical documentation in respect of that vessel; and (b) carry out a relevant conformity assessment procedure in respect of the vessel or have such a procedure carried out.
Declaration of conformity, UK marking and inscriptions for category A vessels
(1) Where the conformity of a category A vessel with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, before placing that vessel on the market, a manufacturer must— (a) draw up a declaration of conformity in accordance with regulation 43 ...; and (b) affix the information set out in paragraph (1B) to— (i) the vessel; (ii) its data plate; or (iii) where paragraph (1A) applies— (aa) to a label affixed to the vessel; or (bb) in a document accompanying the vessel; (1A) This paragraph applies to a vessel that is placed on the market within a period of seven years beginning with IP completion day. (1B) The information referred to in paragraph (1)(b) is— (a) the UK marking; (b) the last two digits of the year in which the UK marking is affixed; (c) the inscriptions. (2) Where a data plate is used, it must be so designed that it cannot be reused and must include a vacant space to enable other information to be provided. (3) The information referred to in paragraph (1)(b) must be visible, legible and indelible. (4) The manufacturer must keep the ... declaration of conformity up-to-date. (5) Where a category A vessel is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.
Inscriptions for category B vessels
(1) Before placing a category B vessel on the market, a manufacturer must affix the following to the vessel or to its data plate— (a) the inscriptions; and (b) the information referred to in regulation 11(1). (2) Where a data plate is used, it must be so designed that it cannot be reused and must include a vacant space to enable other information to be provided. (3) The inscriptions and information referred to in paragraph (1) must be visible, legible and indelible.
Retention by manufacturer of technical documentation and ... declaration of conformity
A manufacturer must keep the technical documentation and the ... declaration of conformity drawn up in respect of a category A vessel and make it available for inspection by the enforcing authorities for a period of 10 years beginning on the day on which the vessel was placed on the market.
Compliance procedures for series production
(1) A manufacturer must ensure, before placing a vessel on the market, that procedures are in place to ensure that series production remains in conformity with Part 2. (2) In doing so, the manufacturer must take adequate account of— (a) any change in vessel design or characteristics; and (b) any change in a designated standard or in another technical specification by reference to which the ... declaration of conformity was drawn up.
Monitoring of vessels made available on the market
(1) When appropriate, having regard to the risks to the health and safety of end-users presented by a vessel, a manufacturer must— (a) carry out sample testing of vessels manufactured by it made available on the market; (b) investigate complaints that vessels manufactured by it are not in conformity with Part 2; (c) keep a register of— (i) complaints that vessels are not in conformity with Part 2; (ii) vessels which are found not to be in conformity with Part 2; and (iii) vessel recalls; and (d) keep distributors informed of any monitoring carried out under this regulation. (2) The manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.
Labelling of vessels
(1) Before placing a vessel on the market, a manufacturer must ensure that the following appear on the vessel or its data plate— (a) a type and serial or batch identification allowing its identification; and (b) the following information— (i) the name, registered trade name or registered trade mark of the manufacturer; and (ii) a postal address at which the manufacturer can be contacted. (2) The information referred to in paragraph (1) must be clear, understandable and intelligible. (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Provision of instructions and safety information
When placing a vessel on the market, a manufacturer must ensure that a vessel is accompanied by instructions and safety information that are clear, legible and in easily understandable English.
Duty of manufacturer to take action in respect of vessels placed on the market which are considered not to be in conformity
(1) A manufacturer who considers, or has reason to believe, that a vessel which the manufacturer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to— (a) bring the vessel into conformity; (b) withdraw the vessel; or (c) recall the vessel. (2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, a manufacturer must immediately inform the market surveillance authority of the risk, ... giving details, in particular, of— (a) the respect in which the vessel is considered not to be in conformity with Part 2; and (b) any corrective measures taken.
Provision of information and cooperation
(1) Following a request from the enforcing authority, and within such period as the authority may specify, a manufacturer must provide the authority with all the information and documentation necessary to demonstrate that a vessel is in conformity with Part 2. (2) A request referred to in paragraph (1)— (a) may only be made during the period of 10 years beginning on the day the vessel was placed on the market; and (b) must be accompanied by the reasons for making the request. (3) The information referred to in paragraph (1)– (a) may be provided electronically; and (b) must be in a language which can be easily understood by the enforcing authority. (4) A manufacturer must, at the request of the enforcing authority, cooperate with that authority on any action taken to— (a) evaluate a vessel in accordance with regulation 58 (evaluation of vessels presenting a risk); or (b) eliminate the risks posed by a vessel which the manufacturer has placed on the market.
Appointment by manufacturer of authorised representative
(1) Subject to regulation 16, a manufacturer may, by written mandate, appoint a person established in the United Kingdom as their authorised representative to perform specified tasks on the manufacturer's behalf. (2) A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, a task under these Regulations remains responsible for the proper performance of that task.
Obligations of authorised representative
(1) The obligations laid down in regulation 4 (design and manufacture in accordance with essential safety requirements and sound engineering practice) and in of regulation 5(a) (technical documentation and conformity assessment for category A vessels) must not form part of an authorised representative's mandate. (2) The mandate must allow the authorised representative to do at least the following in relation to a vessel covered by the mandate— (a) perform the manufacturer's obligations under regulation 8 (retention by manufacturer of technical documentation and ... declaration of conformity); and (b) perform the manufacturer's obligations under regulation 14 (provision of information and cooperation). (3) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and accordingly as far as those duties are concerned, as well as the penalties for failure to comply with those duties, a reference in these Regulations (except in regulation 15) to the manufacturer is to be taken as including a reference to the authorised representative.
Prohibition on placing on the market vessels which are not in conformity
An importer must not place a vessel on the market unless it is in conformity with Part 2.
Requirements which must be satisfied before an importer places a category A vessel on the market
Before placing a category A vessel on the market, an importer must ensure that— (a) the relevant conformity assessment procedure has been carried out; (b) the manufacturer has drawn up the technical documentation; (c) the UK marking and the inscriptions have been affixed in accordance with regulation 6(1)(b) to (d); (d) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels).
Prohibition on an importer placing on the market a category A vessel considered not to be in conformity with the essential safety requirements
(1) Where an importer considers or has reason to believe that a category A vessel is not in conformity with the essential safety requirements, the importer must not place the vessel on the market. (2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, the importer must inform the manufacturer and the market surveillance authority of that risk.
Requirements which must be satisfied before an importer places a category B vessel on the marke t
Before placing a category B vessel on the market, an importer must ensure that— (a) it has been designed and manufactured in accordance with sound engineering practice ; (b) it bears the inscriptions; and (c) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels).
Information identifying importer
(1) Before placing a vessel on the market, an importer must indicate on the vessel ...— (a) the name, registered trade name or registered trade mark of the importer; and (b) a postal address at which the importer can be contacted. (1A) Paragraph (1) does not apply where— (a) either— (i) it is not possible to set out the information referred to in paragraph (1) on the vessel, or (ii) the importer has imported the vessel from an EEA state or Switzerland and places it on the market within the period of seven years beginning with IP completion day, and (b) before placing the vessel on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the vessel. (2) The contact details referred to in paragraph (1) must be in a language which can be easily understood by end-users and the enforcing authority .
Instructions and safety information
When placing a vessel on the market, an importer must ensure that the vessel is accompanied by instructions and safety information that are clear, legible and in easily understandable English.
Transport and storage conditions
Where an importer has responsibility for a category A vessel, the importer must ensure that the conditions under which the vessel is stored or transported do not jeopardise its conformity with the essential safety requirements.
Monitoring by importer of vessels made available on the market
(1) When appropriate, having regard to the risks to the health and safety of end-users presented by a vessel, an importer must— (a) carry out sample testing of vessels made available by the importer on the market; (b) investigate complaints that vessels made available on the market by the importer are not in conformity with Part 2; (c) keep a register of— (i) complaints that vessels are not in conformity with Part 2; (ii) vessels which are found not to be in conformity with Part 2; and (iii) vessel recalls; and (d) keep distributors informed of any monitoring carried out under this regulation. (2) The importer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.
Duty of importer to take action in respect of vessels placed on the market which are considered not to be in conformity
(1) An importer who considers, or has reason to believe, that a vessel which the importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to— (a) bring the vessel into conformity; (b) withdraw the vessel; or (c) recall the vessel. (2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, an importer must immediately inform the market surveillance authority of the risk, ... giving details, in particular, of— (a) the respect in which the vessel is considered not to be in conformity with Part 2; and (b) any corrective measures taken.
Retention by importer of technical documentation and ... declaration of conformity
An importer must, for a period of 10 years beginning on the day on which a category A vessel was placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to the vessel— (a) a copy of the ... declaration of conformity (as referred to in regulation 43); and (b) the technical documentation.
Provision of information and cooperation
(1) Following a request from an enforcing authority, and within such period as the authority may specify, an importer must provide the authority with all the information and documentation necessary to demonstrate that a vessel is in conformity with Part 2. (2) A request referred to in paragraph (1)— (a) may only be made during the period of 10 years beginning on the day that the importer places the vessel on the market; and (b) must be accompanied by the reasons for making the request. (3) The information referred to in paragraph (1)– (a) may be provided electronically; and (b) must be in a language which can be easily understood by the enforcing authority. (4) An importer must, at the request of the enforcing authority, cooperate with the authority on any action taken to— (a) evaluate a vessel in accordance with regulation 58 (evaluation of vessels presenting a risk); or (b) eliminate the risks posed by vessels which the importer has placed on the market.
Duty to act with due care
When making a vessel available on the market a distributor must act with due care to ensure that it is in conformity with Part 2.
Requirements which must be satisfied before a distributor makes available on the market a category A vessel
Before making a category A vessel available on the market, a distributor must ensure that— (a) the vessel— (i) bears the UK marking and the inscriptions; and (ii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English; (b) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels); and (c) the importer has complied with the requirements in regulation 21 (information identifying importer).
Prohibition on a distributor making available on the market a category A vessel not considered to be in conformity with essential safety requirements
(1) Where a distributor considers or has reason to believe that a category A vessel is not in conformity with the essential safety requirements, the distributor must not make the vessel available on the market until it has been brought into conformity. (2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, the distributor must inform the following of that risk– (a) the importer (if there is one); (b) the manufacturer (if there is no importer); and (c) the market surveillance authority.
Requirements which must be satisfied before a distributor makes a category B vessel available on the market
(1) Before making a category B vessel available on the market, a distributor must verify that— (a) the vessel— (i) bears the inscriptions; (ii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English; (b) the manufacturer has complied with the requirements set out in regulation 11 (labelling of vessels); and (c) the importer has complied with the requirements in regulation 21 (information identifying importer). (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Storage and transport conditions
Where a distributor has responsibility for a Category A vessel, the distributor must ensure that the conditions under which it is stored or transported do not jeopardise its conformity with the essential safety requirements.
Duty for distributor to take action in respect of vessels made available on the market which are not in conformity
(1) A distributor who considers or has reason to believe that a vessel which the distributor has made available on the market is not in conformity with Part 2, must make sure that the necessary corrective measures are taken to— (a) bring the vessel into conformity; (b) withdraw the vessel; or (c) recall the vessel. (2) Where the vessel presents a risk to the health or safety of persons, to domestic animals or to property, a distributor must immediately inform the market surveillance authority of the risk ..., giving details, in particular, of— (a) the respect in which the vessel is considered not to be in conformity with Part 2; and (b) any corrective measures taken.
Provision of information and cooperation
(1) Following a request from an enforcing authority, and within such period as the authority may specify, a distributor must provide the authority with all the information and documentation necessary to demonstrate that a vessel is in conformity with Part 2. (2) A request referred to in paragraph (1)— (a) may only be made during the period of 10 years beginning on the day on which the vessel was made available on the market; and (b) must be accompanied by the reasons for making the request. (3) The information referred to in paragraph (1)– (a) may be provided electronically; and (b) must be in a language which can easily be understood by the enforcing authority. (4) A distributor must, at the request of the enforcing authority, cooperate with the authority on any action taken to— (a) evaluate a vessel in accordance with regulation 58 (evaluation of vessels presenting a risk); (b) eliminate the risks posed by a vessel which the distributor has made available on the market.
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor (“A”) is to be considered a manufacturer for the purposes of these Regulations, and is subject to the obligations of the manufacturer under this Part, where A— (a) places a vessel on the market under A's own name or trademark; or (b) modifies a vessel already placed on the market in such a way that it may affect whether the vessel is in conformity with Part 2.
Translation of EU declaration of conformity
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Identification of economic operators
(1) An economic operator (“E”) who receives a request in relation to a vessel from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the authority— (a) any other economic operator who has supplied E with the vessel; and (b) any other economic operator to whom E has supplied the vessel. (2) The relevant period is— (a) in the case of paragraph (1)(a), the period of 10 years beginning on the day on which E was supplied with the vessel; and (b) in the case of paragraph 1(b), the period of 10 years beginning on the day on which E supplied the vessel.
Prohibition on improper use of UK marking
(1) An economic operator must not affix the UK marking to a Category A vessel unless— (a) that economic operator is the manufacturer of the vessel; and (b) the conformity of the vessel with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure. (2) An economic operator must not affix a marking to a vessel which is not the UK marking but which purports to attest that the vessel satisfies the essential safety requirements. (3) An economic operator must not affix to a vessel a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the UK marking. (4) An economic operator must not affix to a vessel any other marking if the visibility, legibility and meaning of the UK marking would be impaired as a result.
Obligations which are met by complying with obligations in the Directive
(1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive; (b) “ CE marking ” has the meaning given to it in Article 2(17); (c) “ harmonised standard ” has the meaning given to it in Article 2(9). (2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing a category A vessel on the market, the manufacturer— (a) ensures that the vessel has been designed and manufactured in accordance with the essential safety requirements set out in Annex I; (b) ensures that the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out; (c) draws up the technical documentation referred to in Annex II; (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (e) affixes a CE marking and the inscriptions, in accordance with Articles 15 and 16(1) to (4); (f) draws up an EU declaration of conformity, in accordance with Article 14; and (g) ensures that the EU declaration of conformity is prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 4(1), 5, 6(1) to (3) and (5) are to be treated as being satisfied; (b) regulations 2(5)(a), 6(4), 8, 9(2), 16(2) and 38 apply subject to the modifications in paragraph (10); (c) Part 3 does not apply; and (d) regulation 62 does not apply. (4) Subject to paragraphs (6) and (7), paragraph (5) applies where, before placing a category A vessel on the market, the importer ensures that— (a) the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex II; and (c) the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III. (5) Where this paragraph applies— (a) the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and (b) regulations 2(5)(a), 19(1), 23 and 26 apply subject to the modifications in paragraph (10). (6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12. (7) Where paragraph (6) applies, paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to have carried out— (a) the conformity assessment procedure set out in Article 13(1)(b); and (b) the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2). (8) Paragraph (9) applies where, before making a category A vessel available on the market, a distributor ensures that the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III. (9) Where this paragraph applies— (a) regulation 29(a)(i) is to be treated as being satisfied; and (b) regulations 2(5)(a), 30(1) and 32 apply subject to the modifications in paragraph (10). (10) The modifications referred to in paragraphs (3)(b), (5)(b) and (9)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking; (c) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedures that apply to the vessel in accordance with Article 13(1) and (2); (f) any reference to “ technical documentation ” is a reference to the technical documentation referred to in Annex II.
Conformity assessment procedure obligation which is met by complying with the Directive
(1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive; (b) “ harmonised standard ” has the meaning given to it in Article 2(9). (2) Subject to paragraphs (4) and (5), paragraph (3) applies where, prior to the manufacture of a category A vessel, the manufacturer ensures that the conformity assessment procedure that applies to that vessel in accordance with Article 13(1) has been carried out. (3) Where this paragraph applies— (a) regulation 40 is to be treated as being satisfied; (b) any reference to “relevant conformity assessment procedure” in regulations 5(b), 6(1), 18(a), 38(b) and 43(c) is to be read as including the conformity assessment procedure referred to in Article 13(1); and (c) any reference to “technical documentation” in regulations 5(a), 8, 18(b) and 26(b) is to be read as including the technical documentation relating to the design of the vessel referred to in Annex II. (4) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12. (5) Where paragraph (4) applies, paragraph (2) is to be treated as requiring the manufacturer to have carried out the conformity assessment procedure set out in Article 13(1)(b).
Further use of the UK marking
(1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive; (b) “ harmonised standard ” has the meaning given to it in Article 2(9). (2) Subject to paragraphs (4) and (5), paragraph (3) applies where, before placing a category A vessel on the market, the manufacturer— (a) ensures that the vessel has been designed and manufactured in accordance with the essential safety requirements set out in Annex I; (b) ensures that the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out; (c) draws up the technical documentation referred to in Annex II; and (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English. (3) Where this paragraph applies— (a) the requirements of regulations 4(1) and 5 are to be treated as being satisfied; (b) except for regulation 43, Part 3 does not apply; (c) regulations 2(5)(a), 6, 8, 9(2), 16(2), 18(a) and (b), 19(1), 23, 26, 30, 32, 38(1) and 62 apply subject to the modifications in paragraph (6); (d) regulation 43 and Schedule 3 apply subject to the modifications in paragraphs (6) and (7). (4) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12. (5) Where paragraph (4) applies, paragraph (2)(b) is to be treated as requiring the manufacturer to have carried out— (a) the conformity assessment procedure set out in Article 13(1)(b); and (b) the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2). (6) The modifications referred to in paragraph (3)(c) and (d) are that— (a) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I; (b) any reference to “designated standard” is to be read as a reference to a harmonised standard; (c) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedure that applies to the vessel in accordance with Article 13(1) and (2); (d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex II. (7) The modifications referred to in paragraph (3)(d) are that— (a) in regulation 43, the reference to Schedule 2 is to be read as a reference to Annex II; (b) in Schedule 3— (i) in paragraph 5 the reference to “relevant statutory requirements” is to be read as including the Directive; (ii) in paragraph 7 the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 13(1) or 13(2).
Qualifying Northern Ireland Goods
(1) Where paragraph (2) applies, a vessel is to be treated as being in conformity with Part 2. (2) This paragraph applies where— (a) a vessel— (i) is in conformity with Part 2, as that Part applies in Northern Ireland; and (ii) is qualifying Northern Ireland goods; and (b) an importer has complied with the obligations set out in paragraph (3). (3) The obligations referred to in paragraph (2)(b) are that, before placing the vessel on the market, the importer— (a) complies with regulation 21; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out in relation to the vessel, in accordance with Part 3, as that Part applies in Northern Ireland; (ii) the manufacturer has drawn up the technical documentation; and (iii) the vessel bears the CE marking. (4) In this regulation— “ CE marking ” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland; “ qualifying Northern Ireland goods ” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; “ technical documentation ” means the documentation referred to in paragraph 2(2)(c) of Part 1 of Schedule 2 to these Regulations, as that Schedule applies in Northern Ireland.
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