Compliance noticesE+W+S
62.—(1) Except in the case of a device which in the opinion of an enforcement authority is likely to compromise the health or safety of any person, where an enforcement authority has reasonable grounds for suspecting that a relevant device or a device for performance evaluation [F1or study] is a device in respect of which there is a failure to comply with these Regulations, that authority may serve upon [F2any person] a notice—
(a)specifying the description of the device to which the notice relates;
(b)stating that the enforcement authority suspects the device is a device in respect of which there is failure to comply with these Regulations and the reasons for that suspicion;
(c)specifying the relevant provision of these Regulations F3...;
(d)requiring the person on whom the notice is served—
(i)to secure that any device to which the notice relates conforms as regards the specified provision within such period as may be specified in the notice, or
(ii)to provide evidence within that period to the satisfaction of the enforcement authority that all the provisions of these Regulations have been complied with in so far as they relate to that device; and
(e)warning the person on whom the notice is served that unless the requirements of sub—paragraph (d) are met, further action may be taken under these Regulations or the 1987 Act in respect of that device or any device of the same type supplied by that person.
(2) Where an enforcement authority serves a notice referred to in paragraph (1), section 14, 16 or 17 of the 1987 Act shall not be applied as respects any device to which the notice relates until the period referred to in paragraph (1)(d) has expired and unless, in relation to the alleged failure to comply with these Regulations, at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.
(3) The notice referred to in paragraph (1) may include directions as to the measures to be taken by the person on whom the notice is served to secure compliance with the provisions of these Regulations, including different ways of securing compliance, and any such directions are requirements of the notice for the purposes of paragraph (2).
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Words in reg. 62(1) inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(5)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 62(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(5)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 62(1)(c) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(5)(iii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 52); 2020 c. 1, Sch. 5 para. 1(1)
Compliance noticesN.I.
62.—(1) Except in the case of a device which in the opinion of an enforcement authority is likely to compromise the health or safety of any person, where an enforcement authority has reasonable grounds for suspecting that a relevant device or a device for performance evaluation is a device in respect of which there is a failure to comply with these Regulations, that authority may serve upon the manufacturer or his authorised representative a notice—
(a)specifying the description of the device to which the notice relates;
(b)stating that the enforcement authority suspects the device is a device in respect of which there is failure to comply with these Regulations and the reasons for that suspicion;
(c)specifying the relevant provision of these Regulations and, where applicable, any relevant provision of the Medical Devices Directives;
(d)requiring the person on whom the notice is served—
(i)to secure that any device to which the notice relates conforms as regards the specified provision within such period as may be specified in the notice, or
(ii)to provide evidence within that period to the satisfaction of the enforcement authority that all the provisions of these Regulations have been complied with in so far as they relate to that device; and
(e)warning the person on whom the notice is served that unless the requirements of sub—paragraph (d) are met, further action may be taken under these Regulations or the 1987 Act in respect of that device or any device of the same type supplied by that person.
(2) Where an enforcement authority serves a notice referred to in paragraph (1), section 14, 16 or 17 of the 1987 Act shall not be applied as respects any device to which the notice relates until the period referred to in paragraph (1)(d) has expired and unless, in relation to the alleged failure to comply with these Regulations, at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.
(3) The notice referred to in paragraph (1) may include directions as to the measures to be taken by the person on whom the notice is served to secure compliance with the provisions of these Regulations, including different ways of securing compliance, and any such directions are requirements of the notice for the purposes of paragraph (2).
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only