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27. The Medical Devices (Northern Ireland Protocol) Regulations 2021(1) are amended in accordance with regulations 28 to 44.
28. In regulation 2(2)—
(a)after “Parts 2,” insert “2A,”; and
(b)after “3” insert “, 3A”.
29. In regulation 3—
(a)in paragraph (1)—
(i)after the definition of “Regulation (EU) 2017/745” insert—
““Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;”
(ii)after the definition of “ethics committee” insert—
““Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;
“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(2).”;
(b)for paragraph (2) substitute—
“(2) Unless otherwise defined in these Regulations—
(a)terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;
(b)terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.”;
(c)for paragraph (3) substitute—
“(3) In these Regulations, a reference to an Article or an Annex is—
(a)in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;
(b)in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.”.
30. For regulation 4 substitute—
4. In these Regulations—
(a)Parts 4, 5 and 6 apply to all devices to which Regulation (EU) 2017/745 and Regulation (EU) 2017/746 apply;
(b)Parts 2 and 3 apply to all devices to which Regulation (EU) 2017/745 applies;
(c)Parts 2A and 3A apply to all devices to which Regulation (EU) 2017/746 applies.”.
31. In the heading of regulation 8, after “free sale” insert “under Regulation (EU) 2017/745”.
32. In regulation 10—
(a)at the end of the heading insert “under Regulation (EU) 2017/745”;
(b)in paragraph (4)(b) omit “or putting the device into service”;
(c)in paragraph (5) omit “or put into service”;
(d)omit paragraph (6).
33. After Part 2 insert—
10A. A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 55 must pay to the Secretary of State a fee of £75.
10B.—(1) The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—
(a)retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 7 of Annex IX applies, and
(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.
(2) In this regulation, the required period is 10 years after the last device was placed on the market.
10C.—(1) This regulation applies if the CE marking is affixed in accordance with Article 18 on the basis of a certificate issued by a notified body established in the United Kingdom.
(2) The CE marking must be accompanied by the UK(NI) indication.
(3) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.
(4) The manufacturer must affix the UK(NI) indication—
(a)visibly, legibly and indelibly, and
(b)before placing the device on the market.
(5) A person may only make available on the market a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.”.
34. In Part 3 (clinical investigations under Regulation (EU) 2017/745), before regulation 11 insert—
A11.—(1) The first subparagraph of Article 62(2) (requirement to have a legal representative established in the Union) does not apply to a clinical investigation conducted in Northern Ireland if all of the following conditions are met—
(a)the clinical investigation is also being conducted in Great Britain;
(b)the clinical investigation is not also being conducted in a Member State;
(c)the sponsor—
(i)is established in Great Britain, or
(ii)has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745;
(d)the sponsor has a contact person established in Northern Ireland in respect of the clinical investigation.
(2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/745 and any communication with that contact person is deemed to be a communication with the sponsor.
(3) The agreement referred to in paragraph (1)(c)(ii) must provide for—
(a)the legal representative to be responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745,
(b)the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and
(c)the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.
(4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—
(a)the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and
(b)the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.
(5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—
(a)the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and
(b)the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.
(6) Where the sponsor has a legal representative established in Great Britain, the application form and the clinical investigation plan drawn up in accordance with chapter II of Annex XV must include the name, address and contact details of the legal representative established in Great Britain.”.
35. In regulation 13 omit paragraph (6).
36. After Part 3 insert—
17B.—(1) The first subparagraph of Article 58(4) (requirement to have a legal representative established in the Union) does not apply to a performance study conducted in Northern Ireland if all of the following conditions are met—
(a)the performance study is also being conducted in Great Britain;
(b)the performance study is not also being conducted in a Member State;
(c)the sponsor—
(i)is established in Great Britain, or
(ii)has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746;
(d)the sponsor has a contact person established in Northern Ireland in respect of the performance study.
(2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/746 and any communication with that contact person is deemed to be a communication with the sponsor.
(3) The agreement referred to in paragraph (1)(c)(ii) must provide for—
(a)the legal representative to be responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746,
(b)the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and
(c)the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.
(4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—
(a)the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and
(b)the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.
(5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—
(a)the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and
(b)the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.
(6) Where the sponsor has a legal representative established in Great Britain, the application form drawn up in accordance with Chapter I of Annex XIV and any clinical performance study plan drawn up in accordance with Part A of Annex XIII must include the name, address and contact details of the legal representative established in Great Britain.
17C.—(1) In Regulation (EU) 2017/746 a reference to an ethics committee is a reference to an ethics committee within the meaning of regulation 3(1).
(2) In relation to a performance study to which Article 58(5)(b) applies, the sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the performance study starts.
17D.—(1) A sponsor notified of a refusal under Articles 66(3), 67(4) or 74(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.
(2) The adjudicator must provide a report to the Secretary of State and the sponsor, setting out any recommendations in respect of the disputed refusal.
(3) The Secretary of State must take the report of the adjudicator into account and decide whether to—
(a)confirm or alter the grounds for the refusal of the application,
(b)authorise the performance study, or
(c)in the case of a refusal under Article 66(3), proceed to consider the application under Article 66.
(4) The Secretary of State must notify the sponsor of the decision in paragraph (3).
(5) The sponsor must pay any fees, costs and expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).
17E. A sponsor of a performance study must hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability in the event of injury or death attributable to participation in the performance study.
17F.—(1) The liquidator or trustee in bankruptcy of a sponsor of a performance study, or of a sponsor’s legal representative or contact person under Article 58(4), must—
(a)retain for the required period any documentation that consists of, or reasonably could consist of, any of the documentation referred to in Annex XIV, and
(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.
(2) In this regulation, the required period is—
(a)in the case of documentation relating to the performance study of a device that was subsequently placed on the market, 10 years after the last device was placed on the market;
(b)in any other case, 10 years after the performance study ended.”.
37. In the heading of Part 4, after “Regulation (EU) 2017/745” insert “and Regulation (EU) 2017/746”.
38. In regulation 18—
(a)in paragraph (1), after “Article 35” insert “of Regulation (EU) 2017/745 and Article 31 of Regulation (EU) 2017/746”;
(b)in paragraph (2), after “Article 46(6)” insert “of Regulation (EU) 2017/745 and Article 42(6) of Regulation (EU) 2017/746”.
39. In regulation 19—
(a)in paragraph (2)—
(i)in sub-paragraph (a), after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;
(ii)in sub-paragraph (b), after “Article 44(10)” insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;
(iii)in sub-paragraph (c), after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;
(b)in paragraph (3) after “under Article 42” insert “of Regulation (EU) 2017/745”;
(c)in paragraph (8)(a), after “Article 42” insert “of Regulation (EU) 2017/745 or Article 38 of Regulation (EU) 2017/746”.
40. In regulation 20 for “provides” substitute “or Regulation (EU) 2017/746 provide”.
41. For regulation 23(1) substitute—
“(1) A person commits an offence if the person contravenes a prohibition or fails to comply with a requirement in a provision of—
(a)the regulations listed in Table 1;
(b)the articles of Regulation (EU) 2017/745 listed in Table 2;
(c)the articles of Regulation (EU) 2017/746 listed in Table 3;
in Schedule 3 to these Regulations.”.
42. In regulation 26—
(a)in paragraph (1), for “and Regulation (EU) 2017/745” substitute “, Regulation (EU) 2017/745 and Regulation (EU) 2017/746”;
(b)in paragraph (2), for “and Regulation (EU) 2017/745” substitute “, Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.
43. In Schedule 2—
(a)the first column (application) in Table 1 (application fees) is amended as follows—
(i)at the end of entry 1 insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;
(ii)in entry 2, after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;
(iii)at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;
(iv)in entry 4—
(aa)after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;
(bb)after “an Annex” insert “to Regulation (EU) 2017/745 or Regulation (EU) 2017/746”;
(v)in entry 5, after “Article 46(1)” insert “of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746”;
(b)the first column (activity) in Table 2 (fees for assessments and reviews) is amended as follows—
(i)in entry 1—
(aa)after “Article 39(4)” insert “of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746”;
(bb)after “Article 38” insert “of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746”;
(cc)at the end insert “of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746”;
(ii)at the end of entry 2 insert “of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746”;
(iii)at the end of entry 3 insert “of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746”;
(iv)in entry 5—
(aa)after “Article 44(7)” insert “of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746”;
(bb)in sub-paragraph (b), after “Regulation (EU) 2017/745” insert “, or Regulation (EU) 2017/746”.
44. In Schedule 3—
(a)for Table 1 substitute—
Regulation | Title of the regulation |
---|---|
5 | Reprocessing of single-use devices |
6 | Requirement on health institutions relating to implanted devices |
7 | Provision of information relating to custom-made devices |
9 | Retention of documentation relating to conformity assessments and custom-made devices |
10 | UK(NI) indication under Regulation (EU) 2017/745 |
10B | Retention of documentation relating to conformity assessments |
10C | UK(NI) indication under Regulation (EU) 2017/746 |
11 | Ethical review of clinical investigations |
12(1) | Prior authorisation of clinical investigations by the Secretary of State |
14 | Damage compensation in relation to clinical investigations |
15 | Retention of documentation relating to clinical investigations |
17C | Ethical review of performance studies |
17E | Damage compensation in relation to performance studies |
17F | Retention of documentation relating to performance studies” |
(b)in Table 2—
(i)for “general obligations on manufacturers” substitute “general obligations of manufacturers”;
(ii)for “32(1), (2)” substitute “32(1) (except the second sentence of the third sub-paragraph), (2)”;
(iii)for “86” substitute “86 (except the second and third sentences of paragraph (2))”;
(c)after Table 2 insert—
Article | Title of the article |
---|---|
5(1) to (3), (5) | Placing on the market and putting into service |
6(1) to (3) | Distance sales |
7 | Claims |
9(3) | Common specifications |
10 (except the second, third or fourth sub-paragraphs of paragraph 13) | General obligations of manufacturers |
11(1), (3), (6) | Authorised representative |
12 | Change of authorised representative |
13 | General obligations of importers |
14 | General obligations of distributors |
15 | Person responsible for regulatory compliance |
16(3), (4) | Cases in which obligations of manufacturers apply to importers, distributors or other persons |
20(1) | Parts and components |
22 | Identification within the supply chain |
29(1) (except the second sentence of the third sub-paragraph), (2) | Summary of safety and performance |
48(1), (2), (3) (except the third sub-paragraph), (4) (except the second sub-paragraph), (7) (except the third sub-paragraph), (8) (except the second sub-paragraph), (9) and (10) | Conformity assessment procedures |
49(3) | Involvement of notified bodies in conformity assessment procedures |
53(1) | Voluntary change of notified body |
57 | General requirements regarding performance studies |
58(1), (2), (4) (except the second sub-paragraph), (5), (6) and (8) | Additional requirements for certain performance studies |
79 | Post-market surveillance plan |
80 | Post-market surveillance report |
81 (except the second and third sentences of paragraph (2)) | Periodic safety update report |
84(1), (3) (except the first sub-paragraph), (5) and (8) | Analysis of serious incidents and field safety corrective actions |
89 (only the final paragraph) | Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance”. |