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The Radio Equipment Regulations 2017 PART 3 — Conformity assessment

40–458 provisions

Presumption of conformity

40

(1) Radio equipment which is in conformity with a designated standard (or part of such a standard), ... must be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard). (2) The presumption in paragraph (1) is rebuttable.

Conformity assessment procedures

41

(1) The manufacturer must perform a conformity assessment of the radio equipment, in all its possible configurations, with a view to meeting the essential requirements. (2) The conformity assessment must take into account all intended operating conditions. (3) In relation to the assessment of compliance with regulation 6(1)(a), the conformity assessment must also take into account all reasonably foreseeable conditions. (4) In relation to the assessment of compliance with regulation 6(1)(a) or (b), one of the following procedures must be used— (a) internal production control set out in Schedule 2 (conformity assessment module A), (b) ...type examination that is followed by the conformity to type based on internal production control set out in Schedule 3 (conformity assessment modules B and C), (c) conformity based on full quality assurance set out in Schedule 4 (conformity assessment module H). (5) In relation to the assessment of compliance with regulation 6(2), where the manufacturer has applied designated standards, ... the manufacturer must use one of the procedures in paragraph (4) for the conformity assessment. (6) In relation to the assessment of compliance with regulation 6(2), where the manufacturer has not applied or has only partly applied designated standards, ... or where designated standards do not exist, the manufacturer must use the procedure in either paragraph (4)(b) or paragraph (4)(c).

Declaration of conformity

42

The ... declaration of conformity for radio equipment must— (a) state that the fulfilment of the essential requirements has been demonstrated in respect of that radio equipment, (b) contain the elements specified and have the model structure set out in Schedule 6 ( ... declaration of conformity) for the relevant conformity assessment procedure followed in respect of that radio equipment.

Simplified ... declaration of conformity

43

(1) Where only a simplified ... declaration of conformity is provided pursuant to regulation 13(3), it must contain the elements specified and have the model structure set out in Schedule 7 (simplified ... declaration of conformity). (2) The full text of the ... declaration of conformity must be made available at the internet address referred to in the simplified ... declaration of conformity.

UK marking

44

(1) The UK marking must be affixed visibly, legibly and indelibly— (a) to the radio equipment or to its data plate, unless that is not possible or not warranted on account of the radio equipment; or (b) where paragraph (1A) applies— (i) to a label affixed to the radio equipment or its data plate; or (ii) to a document accompanying the radio equipment. (1A) For a period of seven years beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the radio equipment or its data plate; or (b) a document accompanying the radio equipment. (2) The UK marking must be affixed visibly and legibly— (a) to the radio equipment packaging; or (b) where paragraph (2A) applies— (i) to a label affixed to the radio equipment packaging; or (ii) a document accompanying the radio equipment packaging. (2A) For a period of seven years beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the radio equipment packaging; or (b) a document accompanying the radio equipment packaging. (3) On account of the nature of the radio equipment, the height of the UK marking affixed to radio equipment may be lower than 5 mm, provided that the marking remains visible and legible. (4) When the conformity assessment procedure in Schedule 4 (conformity assessment module H) has been applied, the UK marking must be followed by the identification number of the approved body which carried out the relevant conformity assessment procedure for the radio equipment. (5) The identification number in paragraph (4) must have the same height as the UK marking and be affixed— (a) by the approved body itself, or (b) under the instructions of the approved body , by the manufacturer or the manufacturer's authorised representative.

UK(NI) indication

44A

(1) Where the CE marking 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 radio equipment, in accordance with this regulation. (2) The UK(NI) indication must be affixed— (a) visibly, legibly and indelibly; and (b) before the radio equipment is placed on the market in Northern Ireland. (3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 44. (4) The UK(NI) indication must be affixed by— (a) the manufacturer; or (b) the manufacturer's authorised representative. (5) When placing radio equipment on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.

Register of notified bodies established in the United Kingdom

44B

(1) The Secretary of State must ensure that— (a) each notified body established in the United Kingdom is assigned an identification number; and (b) there is a register of— (i) notified bodies established in the United Kingdom; (ii) their notified body identification number; (iii) the activities for which they have been notified; (iv) any restrictions on those activities. (2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available. (3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).

Technical documentation

45

(1) The technical documentation produced by the manufacturer for the radio equipment must contain all the relevant data or details of the means used by the manufacturer to ensure that the radio equipment complies with the essential requirements. (2) The technical documentation in paragraph (1) must— (a) contain, at least, the elements set out in Schedule 5 (contents of technical documentation), (b) be drawn up before the radio equipment is placed on the market, and (c) be continuously updated. (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) Where the technical documentation does not comply with the requirements in paragraphs (1) and (2) and in doing so fails to present sufficient relevant data or details of the means used to ensure compliance of radio equipment with the essential requirements, the market surveillance authority may ask the manufacturer or importer to have a test performed, within a specified period, by a body acceptable to the market surveillance authority, at the expense of the manufacturer or the importer to verify conformity with the essential requirements.

Back to The Radio Equipment Regulations 2017 — full text

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