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The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

Type Statutory-Instrument

Publication 2020-12-08

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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Made: 8th December 2020

Coming into force in accordance with regulation 1(2) and (3)

The Treasury has consented to the making of these Regulations as required by paragraphs 3(1) and 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

Citation, commencement and application

1

(1) These Regulations may be cited as the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020.

(2) This regulation and regulation 4 come into force on the day after the day on which these Regulations are made.

(3) Regulations 2 and 3 come into force immediately before IP completion day.

(4) Regulation 2 applies in relation to Northern Ireland only.

Amendment of the Medical Devices Regulations 2002

2

The Medical Devices Regulations 2002[^f00004] are amended in accordance with Schedule 1.

Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

3

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019[^f00005] are amended in accordance with Schedule 2.

Amendment of the Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

4

(1) The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019[^f00006] are amended as follows.

(2) In Schedule 2 (amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019)—

(a) in paragraph 2—

(i) in sub-paragraph (2)(a), in paragraph (1) as substituted by that provision, for “Parts II, III, IV, VIII and IX” substitute “Parts II, III and IV”;

(ii) omit sub-paragraph (3);

(b) omit paragraph 6;

SCHEDULE 1 — Amendment of the Medical Devices Regulations 2002

1

The Medical Devices Regulations 2002 are amended in accordance with this Schedule.

Amendment of regulation 2

2

In regulation 2 (interpretation)—

(a) for the definition of “authorised representative” substitute—

“authorised representative” means a person established within a relevant state, explicitly designated by the manufacturer who is not a person established in a relevant state, who acts for the manufacturer and may be addressed by authorities and bodies in a relevant state instead of the manufacturer with regard to the latter’s obligation under Directive 90/385, Directive 93/42 and Directive 98/79;

(b) in the definition of “EC CAB” omit “EC”;

(c) in the definition of “intended for clinical investigation”, in paragraph (b) for “Member State” substitute “relevant state”;

(d) in the definition of “national standard” for “a Member State of the Community” substitute “a relevant state”;

(e) in the definition of “placing on the market”, for “the Community market” substitute “a relevant market”;

(f) in paragraph (b) of the definition of “putting into service” for “the Community” substitute “a relevant state”;

(g) in the appropriate places insert—

“relevant market” means a market of a relevant state;

“relevant state” means— in relation to any requirement relating to an in vitro diagnostic medical device, Northern Ireland or a Member State of the European Union; in relation to any requirement relating to any other medical device, Northern Ireland or a state in the European Economic Area; a State other than a Member State of the European Union which is a Party to an Association Agreement (where applicable under that Association Agreement);

“UK mutual recognition agreement” means an agreement between the United Kingdom and another country that covers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of the conformity assessment procedures undertaken by each other’s designated bodies;

“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) indication) (EU Exit) Regulations 2020;

“UK responsible person” is to be construed in accordance with regulation 19B(2) for the purposes of Part II, regulation 21C(2) for the purposes of Part III and regulation 44ZA(2) for the purposes of part IV.

Insertion of regulation 10A

3

After regulation 10 (CE marking of general medical devices) insert—

(10A) (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. (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.

Amendment of regulation 16

4

In regulation 16(1) (procedures for general medical devices for clinical investigations), for “the United Kingdom” substitute “Northern Ireland”.

Amendment of regulation 17

5

In regulation 17 (manufacturers etc and conformity assessment procedures for general medical devices) omit paragraph (3).

Substitution of regulation 19

6

For regulation 19 (registration of persons placing general medical devices on the market) substitute—

(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.

Insertion of regulation 19B

7

After regulation 19 insert—

(19B) (1) Paragraph (2) applies in relation to a manufacturer who— (a) does not have a registered place of business in the United Kingdom; (b) has not designated an authorised representative who has a registered place of business in Northern Ireland; and (c) places a relevant device, other than a Class I or custom-made device, on the market in Northern Ireland. (2) A manufacturer to whom this paragraph applies must appoint a person with a registered place of business in the United Kingdom as their UK responsible person to carry out the tasks described in regulations 19(2) and (5).

Insertion of regulation 21B

8

After regulation 21 (scope of Part III) insert—

(21B) (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) 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 relevant devices that are 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. (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) 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 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 the date specified in paragraph (4). (4) The obligations in paragraph (2) begin to apply on 1st May 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 90/385. (21C) (1) Paragraph (2) applies in relation to a manufacturer who— (a) does not have a registered place of business in the United Kingdom; and (b) has not designated an authorised representative who has a registered place of business in Northern Ireland; and (c) places a relevant device, other than a custom-made device, on the market in Northern Ireland. (2) A manufacturer to whom this paragraph applies must appoint a person with a registered place of business in the United Kingdom as their UK responsible person to carry out the tasks described in regulations 21B(2) and (5).

Insertion of regulation 24A

9

After regulation 24 (CE marking of active implantable medical devices) insert—

(24A) (1) Where the CE marking referred to in regulation 24 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 medical device 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 27. (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”;

Amendment of regulation 29

10

In regulation 29(1) (procedures for active implantable medical devices for clinical investigations) for “the United Kingdom” substitute “Northern Ireland”.

Amendment of regulation 30

11

In regulation 30 (manufacturers etc. and conformity assessment procedures for active implantable devices)—

(a) in paragraph (4) for “a Member State” in both places substitute “a relevant state”;

(b) in paragraph (5) for “the Member State” substitute “the relevant state”.

Amendment of regulation 35

12

In regulation 35(2) (determining compliance of in vitro diagnostic medical devices with relevant essential requirements) for “the United Kingdom” substitute “Northern Ireland”.

Insertion of regulation 36A

13

After regulation 36 (CE marking of in vitro diagnostic medical devices) insert—

(36A) (1) Where the CE marking referred to in regulation 36 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 medical device 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 36. (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”.

Amendment of regulation 41

14

In regulation 41 (manufacturers etc and conformity assessment procedures for in vitro diagnostic medical devices), in paragraph (5), for “in the United Kingdom” substitute “in Northern Ireland”.

Substitution of regulation 44

15

For regulation 44 (registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation) substitute—

(44) (1) Paragraph (2) applies— (a) in relation to relevant devices that are Annex II devices or devices for self-testing, 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, or makes available for performance evaluation, any relevant device; (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 relevant devices other than Annex II devices or devices for self-testing, to— (i) a manufacturer who places a device on the Northern Ireland market, or makes such a device available for performance evaluation, and has a registered place of business in Northern Ireland; (ii) an authorised representative with a registered place of business in Northern Ireland. (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— (i) a description of each category of device concerned; (ii) the relevant information in paragraph (7); (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 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, or making them available for performance evaluation, 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, or making them available for performance evaluation; (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) where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1st January 2021; (b) in circumstances other than those described in sub-paragraph (a)— (i) in the case of a relevant device that is a List A device, on 1st May 2021; (ii) in the case of a relevant device that is a device for self-testing, on 1st September 2021; and (iii) in the case of a relevant device that is a List B 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 98/79. (7) In this regulation “relevant information” means— (a) in relation to a new relevant device, a statement indicating that the device is a new relevant device; (b) if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes; (c) if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications; (d) in relation to devices in a list in Annex II and devices for self-testing— (i) all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1; (ii) if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service; (e) in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I. (8) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market. (9) In paragraphs (7) and (8) a device is a “new relevant device” if— (a) there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or (b) use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years. (44ZA) (1) Paragraph (2) applies in relation to a manufacturer who— (a) does not have a registered place of business in the United Kingdom; (b) has not designated an authorised representative who has a registered place of business in Northern Ireland; and (c) places a relevant device a device that is an Annex II device or a device for self-testing, on the market in Northern Ireland; or (d) makes available such a device for performance evaluation. (2) A manufacturer to whom this paragraph applies must appoint a person with a registered place of business in the United Kingdom as their UK responsible person to carry out the tasks described in regulations 44(2) and (5).

Amendment of regulation 45

16

In regulation 45(1) (designation etc. of UK notified bodies), after “any of the tasks of a notified body” insert “with respect to devices to be placed on the market in Northern Ireland”.

Insertion of regulation 47A

17

After regulation 47 (general matters relating to UK notified bodies) insert—

(47A) (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 tasks for which they have been notified; (iv) any restrictions on those tasks. (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).

Amendment of regulation 48

18

In regulation 48 (designation etc. of EC conformity assessment bodies)—

(a) in the heading omit “EC”;

(b) in paragraph (1)—

(i) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”;

(ii) omit “European Community”;

(iii) for “an “EC CAB”” substitute “a “CAB””;

(i) for “an EC CAB” in both places substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”;

(d) in paragraph (4) for “an EC CAB” substitute “a CAB”;

(e) in paragraph (5)—

(i) for “an EC CAB” substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”;

(f) in paragraph (6) omit “EC” in both places;

(g) in paragraph (7)—

(i) for “an EC CAB” substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”;

(h) in paragraph (8)—

(i) for “an EC CAB” in both places substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”.

Amendment of regulation 49

19

In regulation 49 (fees charged by UK notified bodies and EC conformity assessment bodies)—

(a) for the heading substitute “Fees charged by UK notified bodies and conformity assessment bodies”;

(b) in the opening words of paragraph (1) for “EC CAB” substitute “CAB”;

(c) in paragraph (1)(a) for “the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure set out in the Medical Devices Directives” substitute “the Medical Devices Directives or a UK mutual recognition agreement in respect of a conformity assessment procedure set out in the Medical Devices Directives or these Regulations as they apply in Great Britain”;

(d) in paragraph (1)(b)—

(i) for “an EC CAB” in both places substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”;

(e) in paragraph (3) for “EC CAB” substitute “CAB”;

(f) in paragraph (4) for “EC CAB” substitute “CAB”.

Amendment of regulation 53

20

In regulation 53 (fees in connection with the registration of devices and changes to registration details), after “regulation 19” insert “, 21B”.

Amendment of regulation 55

21

In regulation 55 (fees payable in connection with the designation etc. of EC conformity assessment bodies)—

(a) in the heading, omit “EC”;

(b) in paragraph (1), for “an EC CAB” substitute “a CAB”;

(i) for “an EC CAB” substitute “a CAB”;

(ii) for “the Mutual Recognition Agreements” substitute “a UK mutual recognition agreement”.

Amendment of regulation 58

22

In regulation 58(2)(b)(ii) (waivers, reductions and refunds), for “an EC CAB” substitute “a CAB”.

Amendment of regulation 60

23

In regulation 60 (designation etc of authorised representatives)—

(a) in paragraph (1)—

(i) omit “, other than an obligation referred to in regulation 17(3),”;

(ii) for “in the Community or (where appropriate) in a State which is a Party to an Association Agreement” substitute “in a relevant state”;

(b) in paragraph (2)—

(i) for “in the Community or (where appropriate) in a State which is a Party to an Association Agreement” substitute “in a relevant state”;

(ii) in sub-paragraph (a) for “in the Community” substitute “in a relevant state”;

(i) for “the Community” substitute “a relevant state”;

(ii) in sub-paragraph (b)—

(aa) for “the United Kingdom” substitute “Northern Ireland”;

(bb) for “the Community or in a State which is a Party to an Association Agreement” substitute “a relevant state”.

Amendment of regulation 61

24

In regulation 61 (enforcement etc.)—

(a) after paragraph (1) insert—

(1A) Paragraph (1) applies in relation to regulations 10A, 24A and 36A (UK(NI) indication) as it does in relation to any other provision of these Regulations to which it applies.

(b) in paragraph (2) omit “each weights and measures authority in Great Britain and”;

(d) in paragraph (5) omit “authority and”;

(e) in paragraph (6) omit sub-paragraphs (a) and (c).

Amendment of regulation 63

25

In regulation 63 (restriction notices)—

(a) in paragraph (4) omit “or a sheriff”;

(b) in paragraph (5)—

(i) in the words before sub-paragraph (a) omit “or a sheriff”;

(ii) in sub-paragraph (a) omit “or the sheriff”;

(iii) in sub-paragraph (b) omit “or the sheriff”;

(iv) in the words after sub-paragraph (b) omit “or the sheriff”.

Amendment of regulation 65

26

In regulation 65 (centralised system of records etc.) for “the United Kingdom” substitute “Northern Ireland”.

SCHEDULE 2 — Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

1

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 are amended as follows.

Amendment of regulation 1

2

In regulation 1—

(a) for the heading substitute “Citation, commencement and application”;

(b) in regulation (1), for “paragraphs (2) to (4)” substitute “paragraph (2)”;

(d) after paragraph (2) insert—

(2A) These regulations apply in relation to England and Wales and Scotland.

(e) omit paragraphs (3) and (4).

Substitution of regulation 3(2)

3

For regulation 3(2) substitute—

(2) After regulation 1 (citation and commencement) insert— (1ZA) Regulations 19B, 19C, 30A, 44ZA and 44ZB cease to have effect at 23:59 on 30th June 2023. (1A) Schedules 2 and 2A have effect.

Amendment of regulation 3(3)

4

In regulation 3(3)—

(a) after sub-paragraph (a) insert—

(aa) after the definition of “active implantable medical device” insert— - “approved body” is to be construed in accordance with regulation A45;

(b) for sub-paragraph (c) substitute—

(c) omit the definition of “authorised representative”;

(da) omit the definition of “the Community”;

(d) in sub-paragraph (e) for “exit day” substitute “IP completion day”;

(e) in sub-paragraph (f) for “exit day” substitute “IP completion day”;

(f) in sub-paragraph (g) for “exit day” substitute “IP completion day”;

(g) after paragraph (j) insert—

(h) “(ja) omit the definition of “European Economic Area”;”;

(i) in sub-paragraph (l), for “the United Kingdom” substitute “Great Britain”;

(j) for sub-paragraph (q) substitute—

(q) omit the definition of “notified body”;

(k) in sub-paragraph (r)(i) for “United Kingdom” substitute “Great Britain”;

(l) in sub-paragraph (s) for “for “Community” substitute “United Kingdom”” substitute “for “the Community” substitute “Great Britain””;

(m) after sub-paragraph (u) insert—

(ua) after the definition of “third country conformity assessment body” insert— - “UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008[^f00007];

(n) for sub-paragraph (v) substitute—

(v) omit the definition of “UK notified body”;

(o) in sub-paragraph (w) in the definition of “UK responsible person” inserted by sub-paragraph (w), after “established in” insert “any part of”.

Amendment of regulation 3(4)

5

In regulation 3(4) for “exit day” substitute “IP completion day”.

Insertion of regulation 3(4A)

6

After regulation 3(4) insert—

(4A) After regulation 2 (interpretation) insert— (2A) (1) 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 these Regulations as they apply in Northern Ireland; 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. (2) In this regulation, “qualifying Northern Ireland good” has the meaning given in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

Amendment of regulation 3(5)

7

In regulation 3(5) omit sub-paragraphs (a) and (b).

Amendment of regulation 3(6)

8

In—

(a) regulation 3A as inserted by regulation 3(6), in paragraph (1) for “IV, VIII and IX” substitute “and IV”;

(b) regulation 3B as inserted by regulation 3(6), for “notified bodies (including UK notified bodies)” substitute “approved bodies”.

Amendment of regulation 3(7)

9

In regulation 3(7)—

(a) omit regulation 4B and 4C as inserted by regulation 3(7);

(b) in regulation 4D as inserted by regulation 3(7)—

(i) in each place “exit day” occurs substitute “IP completion day”;

(ii) in paragraph (1), for “the day on which” substitute “when”;

(iii) for paragraph (2)(a) substitute—

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

(iv) in paragraph (2)(b) omit “(whether or not Part II applies in respect of the device)”;

(v) for paragraph (3)(a) substitute—

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

(vi) in paragraph (3)(b) omit “(whether or not Part II applies in respect of the device)”;

(vii) in paragraph (4) omit “, with the modifications in paragraph (5)—”;

(viii) omit paragraph (5);

(ix) in paragraph (6) for “the day on which” substitute “when”;

(x) omit paragraph (7);

(xi) in paragraph (8) for “the day on which” substitute “when”;

(xii) for paragraph (9)(a) substitute—

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

(xiii) for paragraph (10) substitute—

(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).

(xiv) in paragraph (11) omit the words from “, with the following modifications” to the end;

(xv) omit paragraph (12);

(d) omit regulation 4F as inserted by regulation 3(7);

(e) omit regulation 4G as inserted by regulation 3(7);

(f) in regulation 4H(2) as inserted by regulation 3(7) for “exit day” substitute “IP completion day”;

(g) in regulation 4J as inserted by regulation 3(7) omit paragraphs (2) and (3);

(h) in regulation 4K as inserted by regulation 3(7) omit paragraphs (2), (3) and (4);

(i) in regulation 4L as inserted by regulation 3(7)—

(i) omit paragraphs (2) and (3);

(ii) in paragraph (4) for “UK notified bodies” substitute “approved bodies”;

(j) in regulation 4M as inserted by regulation 3(7) omit paragraph (2);

(k) in regulation 4N as inserted by regulation 3(7), for the opening words substitute—

Where regulation 7 applies for the purposes of regulation 4D(2)(b) or (3)(b), Directives 2003/12 and 2005/50 apply with the following modifications—;

(l) in regulation 4O as inserted by regulation 3(7), omit paragraph (2);

(m) in regulation 4P as inserted by regulation 3(7), omit paragraph (2);

(n) omit regulation 4Q as inserted by regulation 3(7);

(o) omit regulation 4R as inserted by regulation 3(7);

(p) omit regulation 4S as inserted by regulation 3(7);

(q) in regulation 4T as inserted by regulation 3(7)—

(i) in paragraph (1), for “Parts IV and IX” substitute “Part IV”;

(ii) in paragraph (2)(a) omit “or 69”;

(iii) in paragraph (3) omit “or VIII”;

(iv) in paragraph (4)—

(aa) in sub-paragraph (b) omit “or 69”;

(bb) in sub-paragraph (c) omit “or to “accessory for a medical device” in regulation 69”;

(cc) in sub-paragraph (d) for the words from “the practical application of that definition” to “regulation 137.”, substitute “the practical application of that definition, as having the meaning given to it in regulation 2;”;

(dd) in sub-paragraph (e) omit “or to “accessory for an in vitro diagnostic medical device” in regulation 137”.

Omission of regulation 4(2)

10

Omit regulation 4(2).

Amendment of regulation 4(3)

11

For regulation 4(3) substitute—

(3) In regulation 7(2) (classification of general medical devices) for “a notified body” substitute “an approved body”.

Amendment of regulation 4(4)

12

In regulation 7A as inserted by regulation 4(4)—

(a) in paragraph (1)—

(i) in the opening words omit “(or Part VIII insofar as it applies to relevant devices)”;

(ii) in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”;

(b) for paragraph (2) substitute—

(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.

(i) for the opening words substitute—

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

(ii) for sub-paragraphs (d) to (g) substitute—

(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.

(d) for paragraph (4) substitute—

(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.

Amendment of regulation 4(6)

13

In regulation 4(6), after sub-paragraph (a) insert—

(aa) in paragraph (6) for “his authorised representative” substitute “their UK responsible person”; (ab) in paragraph (8) omit “of Directive 93/42”;

Insertion of regulation 4(6A)

14

After regulation 4(6) insert—

(6A) In regulation 10 (CE marking of general medical devices)— (a) in the heading for “CE Marking” substitute “UK marking”; (b) in paragraph (1)— (i) in the opening words for “CE marking” substitute “UK marking”; (ii) in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008 [^f00008]” ; (iii) in sub-paragraph (c) for “notified body” substitute “approved body”; (c) in paragraph (2)— (i) in the opening words for “CE marking” substitute “UK marking”; (ii) in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008”; (iii) in sub-paragraph (c) for “notified body” substitute “approved body”; (d) in paragraph (3)— (i) in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”; (ii) in the words following sub-paragraph (b)— (aa) for “CE marking” substitute “UK marking”; (bb) for “notified body” substitute “approved body”; (e) in paragraph (4)— (i) in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”; (ii) in the words following sub-paragraph (b)— (aa) for “CE marking” substitute “UK marking”; (bb) for “notified body” substitute “approved body”; (f) in paragraph (5) in the words after sub-paragraph (c), for both references to “CE marking” substitute “UK marking”.

Insertion of regulation 4(6B)

15

After regulation 4(6A) insert—

(6B) For regulation 11 (CE marking of general medical devices that come within the scope of more than one Directive) substitute— (11) 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.

Substitution of regulation 4(7)

16

For regulation 4(7) substitute—

(7) In regulation 12 (exemptions from regulations 8 and 10)— (a) in paragraph (1) omit “Directive 93/42 or”; (b) in paragraph (3)(a) for “CE marking” substitute “UK marking”; (c) in paragraph (5) for “CE marking” substitute “UK marking”; (d) after paragraph (5) insert— (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.

Insertion of regulation 4(7A)

17

After regulation 4(7) insert—

(7A) In regulation 13 (procedures for affixing a CE marking to general medical devices)— (a) in the heading for “CE marking” substitute “UK marking”; (b) for each reference to “Directive 93/42” substitute “this Part”; (c) for “CE marking”, each time those words occur, substitute “UK marking”; (d) for “his authorised representative”, each time those words occur, substitute “their UK responsible person”.

Insertion of regulation 4(7B)

18

After regulation 4(7A) insert—

(7B) In regulation 14 (procedures for systems and procedure packs, and for devices to be sterilised before use)— (a) in paragraph (4A) for “notified body” substitute “approved body”; (b) in paragraph (5)(a) for “CE marking” substitute “UK marking”.

Insertion of regulation 4(7C)

19

After regulation 4(7B) insert—

(7C) In regulation 15 (procedures for custom-made general medical devices) for “his authorised representative” substitute “their UK responsible person.

Insertion of regulation 4(7D)

20

After regulation 4(7C) insert—

(7D) In regulation 16 (procedures for general medical devices for clinical investigation)— (a) for “his authorised representative” each time those words occur, substitute “their UK responsible person”; (b) in paragraph (1), for “the United Kingdom” substitute “Great Britain”; (c) in paragraph (2)— (i) for “CE marking” substitute “UK marking”; (ii) for “CE marked” substitute “UK marked”; (d) in paragraph (4) for “or authorised representative” substitute “or UK responsible person”; (e) in paragraph (11) for “single authorised representative” substitute “single UK responsible person”.

Substitution of regulation 4(8)

21

For regulation 4(8) substitute—

(8) In regulation 17[^f00009] (manufacturers etc. and conformity assessment procedures for general medical devices)— (a) for “his authorised representative” each time that those words occur substitute “their UK responsible person”; (b) for each reference to “Directive 93/42” substitute “this Part”; (c) omit paragraph (3).

Substitution of regulation 4(9)

22

For regulation 4(9) substitute—

(9) In regulation 18 (UK notified bodies and the conformity assessment procedures for general medical devices)— (a) in the heading, for “UK notified bodies” substitute “Approved bodies”; (b) in paragraph (1)— (i) in the opening words, for “A UK notified body” substitute “An approved body”; (ii) in sub-paragraph (a) omit “in accordance with Directive 93/42”; (iii) in sub-paragraph (b) omit the words from “including in particular” to “EEA State”; (c) in paragraph (2) for “a UK notified body” substitute “an approved body”; (d) in paragraph (3)— (i) for “a UK notified body” substitute “an approved body”; (ii) for “his authorised representative”, in both places, substitute “the manufacturer’s UK responsible person”; (e) omit paragraph (4).

Insertion of regulation 4(10)

23

After regulation 4(9) insert—

(10) In regulation 19 (registration of persons placing general medical devices on the market)— (a) in paragraphs (1), (3), (4) and (5) for “Subject to paragraph (6), for” substitute “For”; (b) in paragraph (2)(a) for “CE marked” substitute “UK marked”; (c) in paragraphs (2)(a) and (b) for “the United Kingdom” in each place substitute “Great Britain”; (d) in paragraph (3)— (i) in the opening words for— (aa) “the United Kingdom” in both places substitute “Great Britain”; (bb) “the Community or in a State which is a Party to an Association Agreement” substitute “the United Kingdom”; (ii) omit sub-paragraph (c) and “;and” which precedes it; (e) in paragraph (4), in the opening words for— (i) “the United Kingdom” in both places substitute “Great Britain”; (ii) “CE marked” substitute “UK marked”; (f) in paragraph (5)— (i) for “the United Kingdom” in each place substitute “Great Britain”; (ii) omit “(including the authorised representative of a manufacturer of a Class IIa, IIb or III device who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement)”; (g) omit paragraph (6).

Insertion of regulation 4(11)

24

After regulation 4(10) insert—

(11) Before the heading to Part III (active implantable medical devices) insert— (19B) (1) In this regulation— (a) “the Directive” means Directive 93/42[^f00010] and any reference to an Article or Annex is a reference to that Article or Annex in the Directive as amended from time to time; (b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it has effect in EU law[^f00011]; (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) 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; (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) draws up 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. (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; (c) undertakes to keep the declarations required by Article 12 for the period specified in Article 12(4); and (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. (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”. (19C) (1) In this regulation— (a) “the Regulation” means Regulation (EU) 2017/745[^f00012], 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; (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 has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI. (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”.

Amendment of regulation 5(3)

25

In regulation 21A as inserted by regulation 5(3)—

(a) in paragraph (1)—

(i) in the opening words, omit “or Part VIII insofar as it applies to relevant devices”;

(ii) in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”;

(b) for paragraph (2) substitute—

(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.

(i) for the opening words substitute—

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

(ii) for sub-paragraphs (d) to (g) substitute—

(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.

(d) for paragraph (4) substitute—

(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.

Insertion of regulation 5(4A)

26

After regulation 5(4) insert—

(4A) In regulation 24 (CE marking of active implantable medical devices)— (a) in the heading for “CE marking” substitute “UK marking”; (b) for “CE marking” each time those words occur substitute “UK marking”; (c) for each reference to “Annex 9” substitute “Annex 2 of Regulation 765/2008”; (d) for “notified body” each time those words occur— (i) in each of paragraphs (1)(c) and(2)(c); (ii) in the words following paragraphs (3)(b) and (4)(b), substitute “approved body”.

Insertion of regulation 5(4B)

27

After regulation 5(4A) insert—

(4B) For regulation 25 (CE marking of active implantable medical devices that come within the scope of more than one Directive) substitute— (25) 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.

Substitution of regulation 5(5)

28

For regulation 5(5) substitute—

(5) In regulation 26 (exemptions from regulations 22 and 24)— (a) in paragraph (1) omit “Directive 90/385 or”; (b) in paragraph (3) for “CE marking” substitute “UK marking”; (c) after paragraph (3) insert— (4) Regulations 22 and 24 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 22 and 24, may be placed on the market. (5) In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Insertion of regulation 5(5A)

29

After regulation 5(5) insert—

(5A) In regulation 27 (procedures for affixing a CE marking to active implantable medical devices)— (a) in the heading for “CE marking” substitute “UK marking”; (b) in the opening words for— (i) “CE marking” substitute “UK marking”; (ii) “his authorised representative” substitute “their UK responsible person”; (c) in sub-paragraphs (b) and (c) for “Directive 90/385” substitute “this Part”.

Insertion of regulation 5(5B)

30

After regulation 5(5A) insert—

(5B) In regulation 28 (procedures for custom-made active implantable medical devices), in the opening words, for “his authorised representative” substitute “their UK responsible person.

Insertion of regulation 5(5C)

31

After regulation 5(5B) insert—

(5C) In regulation 29 (procedures for active implantable medical devices for clinical investigations)— (a) for “his authorised representative” each time those words occur, substitute “their UK responsible person”; (b) in paragraph (1), in the opening words, for “the United Kingdom” substitute “Great Britain”; (c) in paragraph (3), for “or authorised representative” substitute “or UK responsible person”; (d) in paragraph (10) for “single authorised representative” substitute “single UK responsible person”.

Substitution of regulation 5(6)

32

For regulation 5(6) substitute—

(6) In regulation 30 (manufacturers etc. and conformity assessment procedures for active implantable medical devices)— (a) in paragraphs (1) and (2) for the words “his authorised representative” both times they occur substitute “their UK responsible person”; (b) in paragraph (3) for the opening words substitute—— (3) The manufacturer of a relevant device, who places devices on the market, in accordance with the procedure referred to in Article 9(2) of Directive 90/385, or, if not the manufacturer, the person placing custom-made devices on the market under that Article, must provide the Secretary of State with— (c) omit paragraphs (4) and (5).

Substitution of regulation 5(7)

33

For regulation 5(7) substitute—

(7) In regulation 31 (UK notified bodies and the conformity assessment procedures for active implantable medical devices)— (a) in the heading, for “UK notified bodies” substitute “Approved bodies” (b) in paragraph (1)— (i) for “A UK notified body” substitute “An approved body”; (ii) for “Directive 90/385” substitute “this Part”; (iii) for “his authorised representative” substitute “their UK responsible person”; (c) in paragraph (2) for “a UK notified body” substitute “an approved body”; (d) in paragraph (3)— (i) for the words from “Where” to “representative” substitute “Where an approved body and a manufacturer or the manufacturer’s UK responsible person”; (ii) for “his authorised representative” substitute “the manufacturer’s UK responsible person”.

Insertion of regulation 5(8)

34

In regulation 5 at the end insert—

(8) After regulation 30 (manufacturers etc. and conformity assessment procedures for active implantable medical devices), insert— (30A) (1) In this regulation— (a) “the Directive” means Directive 90/385[^f00013] and any reference to an Article or Annex is a reference to that Article or Annex in the Directive as amended from time to time; (b) “Regulation 722/2012” means Commission Regulation (EU) 722/2012[^f00014] as it has effect in EU Law; (c) “CE marking” means the CE marking required by Article 12 and shown in Annex 9; (d) “harmonised standard” is to be construed in accordance with Article 5. (2) Where paragraph (3) applies regulations 22, 24(1) to (4), 25 and 27 are treated as being satisfied. (3) 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 (EU) 722/2012, which apply to it; or (ii) that paragraphs (8) and (9) apply; (b) ensures that the relevant conformity assessment procedure that applies to the device, where the device is a device other than those which are custom-made or intended for clinical investigations, has been carried out in accordance with Article 9; (c) ensures that the documentation required by the relevant 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 2, 3, 4 or 5; (f) draws up an EU Declaration of Conformity in accordance with Article 9; and (g) ensures that the declaration of conformity is prepared in or translated into English. (4) Where paragraph (5) applies, regulations 25 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 required by Section 1 and specified in Section 2.1 of Annex 6, 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 6; (ii) to keep all documentation required by Annex 6 for the period specified in Section 4 of Annex 6; and (iii) to pass on the statement mentioned in sub-paragraph (a) with the custom-made device so that it may be made available to the patient on request. (6) Where paragraph (7) applies, regulations, 22 and 29 are treated as being satisfied. (7) 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 Section 2.2 of Annex 6; (b) has provided an undertaking to keep available for five years the documentation referred to in Section 3.1 and 3.2 of Annex 6; 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 Section 3.2 of Annex 6. (8) Where paragraph (9) 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). (9) 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. (10) For the purpose of this regulation in regulations 24(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

Omission of regulation 6(2)

35

Omit regulation 6(2).

Amendment of regulation 6(3)

36

In regulation 33A as inserted by regulation 6(3)—

(a) in paragraph (1)—

(i) in the opening words, omit “, or Part IX insofar as it applies to relevant devices,”;

(ii) in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”;

(b) for paragraph (2) substitute—

(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— (i) a description of the relevant device; and (ii) the relevant information in paragraph (4); and (c) that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(i) for the opening words substitute—

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

(ii) for sub-paragraphs (d) to (g) substitute—

(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.

(d) in paragraph (6) for “or other market” in both places substitute “or EEA market”;

(e) for paragraph (7) substitute—

(7) In paragraph (3)— (a) the references to “technical documentation” are to be construed in accordance with Annexes III to VIII; (b) the references to “declaration of conformity” are to be construed in accordance with Annexes III, IV, V and VII.

Substitution of regulation 6(4)

37

For regulation 6(4) substitute—

(4) In regulation 35 (determining compliance of in vitro diagnostic medical devices with relevant essential requirements)— (a) in paragraph (2), omit the words from “if the device may reach a final user” to the end; and (b) in paragraph (3) for “national standard” substitute “designated standard”.

Insertion of regulation 6(4A)

38

After regulation 6(4) insert—

(4A) In regulation 36 (CE marking of in vitro diagnostic medical devices)— (a) in the heading for “CE marking” substitute “UK marking”; (b) for “CE marking” each time those words occur substitute “UK marking”; (c) for each reference to “Annex X” substitute “Annex 2 of Regulation 765/2008”; (d) for “notified body” each time those words occur substitute “approved body”.

Insertion of regulation 6(4B)

39

After regulation 6(4A) insert—

(4B) For regulation 37 (CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive) substitute— (37) 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.

Substitution of regulation 6(5)

40

For regulation 6(5) substitute—

(5) In regulation 39 (exemptions from regulations 34, 36 and 38)— (a) in paragraph (1)(b) omit “Directive 98/79 or”; (b) in paragraph (2) for “CE marking” substitute “UK marking”; (c) after paragraph (2) insert— (3) Regulations 34 and 36 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 34 and 36, may be placed on the market. (4) In paragraph (3), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 34 and 36, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Insertion of regulation 6(5A)

41

After regulation 6(5) insert—

(5A) In regulation 40 (procedures for affixing a CE marking to in vitro diagnostic medical devices)— (a) in the heading and in each place in that regulation that “CE marking” occurs substitute “UK marking”; (b) for “his authorised representative”, each time those words occur, substitute “their UK responsible person”; (c) for each reference to “Directive 98/79” substitute “this Part”.

Substitution of regulation 6(6)

42

For regulation 6(6) substitute—

(6) In regulation 41 (manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices)— (a) for each reference to “his authorised representative” substitute “their UK responsible person”; (b) for both references to “Directive 98/79” substitute “this Part”; (c) in paragraph (1) for “that apply to him” substitute “that apply to the manufacturer or, as the case may be, their UK responsible person”; (d) in paragraph (3)(c) for “notified bodies” substitute “approved bodies”; (e) in paragraph (5)— (i) omit from the beginning to “established”; (ii) omit “in the United Kingdom”.

Substitution of regulation 6(7)

43

For regulation 6(7) substitute—

(7) In regulation 42 (UK notified bodies and the conformity assessment procedures for in vitro diagnostic devices)— (a) in the heading, for “UK notified bodies” substitute “Approved bodies”; (b) in paragraph (1)— (i) in the opening words, for “A UK notified body” substitute “An approved body”; (ii) in sub-paragraph (a) omit “in accordance with Directive 98/79”; (iii) in sub-paragraph (b) omit the words from “including in particular” to the end of that sub-paragraph (but not the “and” following it); (iv) in sub-paragraph (c) for “his authorised representative” substitute “their UK responsible person”; (c) in paragraph (2) for “a UK notified body” substitute “an approved body”; (d) in paragraph (3)— (i) for “a UK notified body” substitute “an approved body”; (ii) for “his authorised representative” in both places it occurs substitute “their UK responsible person”.

Insertion of regulation 6(8)

44

After regulation 6(7) insert—

(8) In regulation 43 (devices for performance evaluation)— (a) in the opening words, for “his authorised representative” substitute “their UK responsible person”; (b) in paragraph (b)(ii), for “the Directive” substitute “these Regulations”.

Insertion of regulation 6(9)

45

After regulation 6(8) insert—

(9) In regulation 44 (registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation)— (a) in paragraph (1)— (i) in the opening words, for “Subject to paragraph (3), for” substitute “For”; (ii) in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”; (iii) in sub-paragraph (b) for— (aa) “an authorised representative” substitute “a UK responsible person”; (bb) “that he is the authorised representative of the manufacturer” substitute “that they are the manufacturer’s UK responsible person”; (iv) in sub-paragraph (c) for “Community market” in both places substitute “the United Kingdom or EEA market”; (v) in sub-paragraph (g)(ii) for “the United Kingdom” substitute “Great Britain”; (b) in paragraph (2)— (i) in sub-paragraph (a) for “the United Kingdom” substitute “Great Britain”; (ii) in sub-paragraph (b)— (aa) for “the United Kingdom” in both places substitute “Great Britain”; (bb) for “the Community or in a State which is a Party to an Association Agreement” substitute “the United Kingdom”; (cc) for “his authorised representative” substitute “their UK responsible person”; (c) omit paragraph (3).

Insertion of regulation 6(10)

46

After regulation 6(9) insert—

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