The Medical Devices Regulations 2002

Registration of persons placing general medical devices on the market E+W+S

19.—(1)  [F1 For] the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person to whom this paragraph applies shall—

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

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

(2) Paragraph (1) applies to—

(a) a manufacturer with a registered place of business in [F2 Great Britain] who, under his own name, places on the market in [F2 Great Britain] a relevant device which is a Class 1 device or a custom-made device, other than a system or procedure pack which is not [F3 UK marked]; and

(b) a person with a registered place of business in [F4 Great Britain] who sterilises before use relevant devices designed by their manufacturer to be sterilised before use.

(3) [F5 For] the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in [F6 Great Britain] who places a device mentioned in paragraph (2) on the market in [F6 Great Britain] on behalf of a manufacturer who does not have a registered place of business in [F7 the United Kingdom] shall inform the Secretary of State of—

(a) the address of his registered place of business;

(b) the category of device; F8 ...

F8 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) [F9 For] the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in [F10 Great Britain] who places a system or procedure pack which is not [F11 UK marked] on the market in [F10 Great Britain], or who sterilises systems or procedure packs before they are placed on the market, shall—

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

(b) supply the Secretary of State with descriptions of the devices which are included in any such system or procedure pack in a manner sufficient to identify them.

(5) [F12 For] the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in [F13 Great Britain] who places a relevant device which is a Class IIb or III device on the market in [F13 Great Britain] F14 ... shall, if the Secretary of State so requests, supply the Secretary of State with all data allowing for the identification of the device together with the label and the instructions for use for when the device is put into service within [F13 Great Britain].

F15 (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Word in reg. 19(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), 4(10)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 19(2)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 19(2)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 19(2)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in reg. 19(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 19(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(d)(i)(aa) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 19(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(d)(i)(bb) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 19(3)(c) and word 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), 4(10)(d)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in reg. 19(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in reg. 19(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(e)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in reg. 19(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F12 Word in reg. 19(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in reg. 19(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(f)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in reg. 19(5) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(10)(f)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

F15 Reg. 19(6) 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), 4(10)(g) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 23); 2020 c. 1, Sch. 5 para. 1(1)

[F16 Registration of persons placing general medical devices on the market N.I.

19.— (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) a UK responsible person;

(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 and 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) in the case of a UK responsible person, supply the Secretary of State with—

(i) written evidence that they have been appointed as a UK responsible person;

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

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

(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) A UK responsible person 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 notified body of that termination.

(6) In this regulation the references to “technical documentation” and “declaration of conformity” are to be construed in accordance with Directive 93/42.]

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F16 Reg. 19 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 6