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

(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.

• (c) in paragraph (3)—

• (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—

(10) Before the heading to Part V (notified bodies, conformity assessment bodies and marking of products) insert— (44ZA) (1) In this regulation— (a) any reference to an Article or Annex is a reference to that Article or Annex in Directive 98/79[^f00015] as amended from time to time; (b) “Regulation 722/2012”[^f00016] means Commission Regulation (EU) 722/2012 as it applies in the European Union; (c) “CE marking” means the CE marking required by Article 16 and shown in Annex X; (d) “harmonised standard” is to be construed in accordance with Article 5. (2) Where paragraph (3) applies regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied. (3) This paragraph applies where, before placing a relevant device 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 (6) and (7) apply; (b) ensures that the relevant conformity assessment procedure that applies to the device 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 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 III, IV, V, VI or VII; (f) draws up an EU Declaration of Conformity in accordance with Article 9; (g) ensures that the declaration of conformity is prepared in or translated into English. (4) Where paragraph (5) applies, regulation 43 is treated as being satisfied. (5) This paragraph applies where before a relevant device intended for performance evaluation is made available in Great Britain for the purpose of a performance evaluation, the manufacturer— (a) has supplied the relevant written notice which must be in English in the form required by Sections 1 and 2 of Annex VIII; (b) has provided an undertaking to the Secretary of State to keep available the documentation required by Annex VIII for the period specified in Section 3 of Annex VIII; (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 Section 3 of Annex VIII. (6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4). (7) This paragraph applies where— (a) 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; or (b) a relevant device is in conformity with a common technical specification. (8) For the purpose of this regulation in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”. (44ZB) (1) In this regulation— (a) any reference to an Article or Annex is a reference to that Article or Annex in Regulation (EU) 2017/746[^f00017] as it has effect in EU law; (b) “CE marking” means the CE marking required by Article 18 and presented in Annex V; (c) “harmonised standard” has the meaning given in Article 2(73); (d) “sponsor” has the meaning given in Article 2(57). (2) Where paragraph (3) applies, regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied. (3) This paragraph applies where, before placing a relevant device 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 (6) and (7) apply; (b) ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 48; (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 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 procedures set out in Annexes IX, X and XI; (f) draws up an EU declaration of conformity in accordance with Article 17; and (g) ensures that the declaration of conformity is prepared in or translated into English. (4) Where paragraph (5) applies, regulation 43 is treated as being satisfied. (5) This paragraph applies where, before a person supplies or makes available a device falling within Part IV for the purposes of performance evaluation, the sponsor of the performance evaluation— (a) has been able to provide the Secretary of State with the required notice in the form of the application required by Chapter I of Annex XIV in English; (b) has been able to provide the Secretary of State with an undertaking to keep available information contained in the application in accordance with Chapter II of Annex XIV. (6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4). (7) This paragraph applies where— (a) 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; or (b) a relevant device is in conformity with a common technical specification. (8) For the purpose of this regulation,in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.

Substitution of regulation 7

47

For regulation 7 substitute—

(7) (1) Part V of the 2002 Regulations is amended as follows. (2) In the Part V heading for “Notified Bodies” substitute “Approved Bodies”. (3) Before regulation 45 insert— (A45) (1) An approved body is a conformity assessment body which— (a) has been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); or (b) immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation. (2) In this regulation— - “UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”. (4) In regulation 45 (designation etc. of UK notified bodies)— (a) in the heading for “UK notified bodies” substitute “approved bodies”; (b) in paragraph (1)— (i) for “article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79” substitute “these Regulations”; (ii) for “a notified body” substitute “an approved body”; (iii) for “a “UK notified body”” substitute “an “approved body””; (c) in the opening words of paragraph (2) for “a notified body” substitute “an approved body”; (d) in paragraph (2)(a)— (i) for “Directive 90/385” substitute “Part III”; (ii) for “notified bodies set out in Annex 8 of that Directive” substitute “approved bodies set out in Annex 8 of Directive 90/385”; (e) in paragraph (2)(b)— (i) for “Directive 93/42” substitute “Part II”; (ii) for “notified bodies set out in Annex XI of that Directive” substitute “approved bodies set out in Annex XI of Directive 93/42”; (f) in paragraph (2)(c)— (i) for “Directive 98/79” substitute “Part IV”; (ii) for “notified bodies set out in Annex IX of that Directive” substitute “approved bodies set out in Annex IX of Directive 98/79”; (g) in paragraph (2)(d) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”; (h) in paragraph (4) for “a UK notified body” substitute “an approved body”; (i) in paragraph (5)(c) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”; (j) in paragraph (6)— (i) for “the notified body’s request” substitute “the approved body’s request”; (ii) for “notified body” substitute “approved body”; (k) in paragraph (7), in the opening words, for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”; (l) in paragraph (8)— (i) in the opening words for “a UK notified body” substitute “an approved body”; (ii) in sub-paragraph (b) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”. (5) In regulation 46 (choice of notified bodies and conformity assessment bodies)— (a) for the heading substitute “Choice of approved bodies and conformity assessment bodies”; (b) for “a notified body” substitute “an approved body” (c) for “his authorised representative” substitute “the manufacturer’s UK responsible person”; (d) for “any notified body” substitute “any approved body”. (6) In regulation 47 (general matters relating to UK notified bodies)— (a) for the heading substitute “General matters relating to approved bodies”; (b) in paragraph (1)— (i) for “A UK notified body” substitute “An approved body”; (ii) for “his authorised representative” substitute “the manufacturer’s UK responsible person”; (iii) for “a notified body” substitute “an approved body”; (iv) for “the Medical Devices Directives” substitute “these Regulations”; (c) in paragraph (2)— (i) for “his authorised representative” substitute “the manufacturer’s UK responsible person”; (ii) for “a UK notified body” substitute “an approved body”; (d) in paragraph (3)— (i) for “his authorised representative supplies to a notified body” substitute “the manufacturer’s UK responsible person supplies to an approved body”; (ii) for “the Medical Devices Directives” substitute “these Regulations”; (iii) omit “if the notified body is within the United Kingdom”; (iv) omit “or some other Community language acceptable to the notified body concerned”; (e) in paragraph (4)— (i) for “A UK notified body” substitute “An approved body”; (ii) for “other notified bodies” substitute “other approved bodies”; (f) in paragraph (5)— (i) in the opening words for “a UK notified body” substitute “an approved body”; (ii) in sub-paragraph (a) for “the Medical Devices Directives” substitute “these Regulations”; (iii) in the words after sub-paragraph (b) for “notified body”, both times those words occur, substitute “approved body”; (g) in paragraph (6)— (i) for “a UK notified body” substitute “an approved body”; (ii) for “the Mutual Recognition Agreements” in both places substitute “a mutual recognition agreement”; (h) in paragraph (8)— (i) for “A UK notified body” substitute “an approved body”; (ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”. (7) After regulation 47 insert— (47A) (1) The Secretary of State must ensure that— (a) each approved body is assigned an identification number; and (b) there is a register of— (i) approved bodies; (ii) their approved body identification number; (iii) the tasks for which they have been designated; and (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). (8) 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 mutual recognition agreement”; (ii) omit “European Community”; (iii) for “an “EC CAB”” substitute “a “CAB””; (c) in paragraph (2)— (i) for “an EC CAB” in both places substitute “a CAB”; (ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”; (d) in paragraph (4) for “an EC CAB” substitute “a CAB”; (e) in paragraph (5)(b)— (i) for “an EC CAB” substitute “a CAB”; (ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”; (f) in paragraph (6) omit “EC” in both places; (g) in paragraph (7), in the opening words— (i) for “an EC CAB” substitute “a CAB”; (ii) for “the Mutual Recognition Agreements” substitute “a 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 mutual recognition agreement”. (9) In regulation 49 (fees charged by UK notified bodies and EC conformity assessment bodies)— (a) for the heading substitute “Fees charged by approved bodies and conformity assessment bodies”; (b) in paragraph (1), in the opening words for “A UK notified body or EC CAB” substitute “An approved body or CAB”; (c) for paragraph (1)(a) substitute— (a) in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and (d) in paragraph (1)(b)— (i) for “an EC CAB” in both places it occurs substitute “a CAB”; (ii) for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”; (e) in paragraph (3)— (i) in the opening words for “UK notified body or EC CAB” substitute “approved body or CAB”; (ii) in sub-paragraph (a) for “notified body” substitute “approved body”; (f) in paragraph (4) for “UK notified body or EC CAB” substitute “approved body or CAB”. (10) In regulation 50 (products incorrectly marked with a notified body or conformity assessment body number)— (a) in the heading for “a notified body” substitute “an approved body”; (b) in paragraph (1) for “a notified body” in each place it occurs substitute “an approved body”; (c) in paragraph (2)— (i) for “a notified body” each place it occurs substitute “an approved body”; (ii) in sub-paragraph (b) for “the notified body” substitute “the approved body”; (d) in paragraph (3)(a) for “a notified body” substitute “an approved body”; (e) in paragraph (3)(b) for “notified body” in both places substitute “approved body”; (f) in paragraph (4) for “a notified body” substitute “an approved body”. (11) In regulation 51 (products incorrectly marked with a CE marking) and in the heading, for “CE marking” in each place it occurs substitute “UK marking”.

Substitution of regulation 8(2) and (3)

48

For regulation 8(2) and (3) substitute—

(2) In regulation 53 (fees in connection with the registration of devices and changes in registration details) for “regulation 19 or 44” substitute “regulation 7A, 19, 21A, 33A or 44”. (3) In regulation 54 (fees payable in connection with the designation of UK notified bodies)— (a) for the heading substitute “Fees payable in connection with the designation of approved bodies”; (b) in paragraph (1) for “a notified body” substitute “an approved body”; (c) in paragraph (3) for “the Mutual Recognition Agreements” in both places substitute “a mutual recognition agreement”; (d) in paragraph (3C) for “A UK notified body” substitute “An approved body”; (e) in paragraph (3D)— (i) for “a UK notified body” substitute “an approved body”; (ii) for “the UK notified body” substitute “the approved body”; (f) in paragraph (3E) for “A UK notified body” substitute “An approved body”.

Insertion of regulation 8(4A)

49

After regulation 8(4) insert—

(4A) In regulation 56 (fees payable in relation to clinical investigation notices), in paragraph (2), for “his authorised representative” substitute “their UK responsible person”.

Amendment of regulation 8(5)

50

For regulation 8(5) substitute—

(5) In regulation58 (waivers, reductions and refunds)— (a) in paragraph (2)(b)(i) for “a notified body” substitute “an approved body”; (b) in paragraph (2)(b)(ii) for “an EC CAB” substitute “a CAB”.

Substitution of regulation 9(4)

51

For regulation 9(4) substitute—

(4) In regulation 61 (enforcement etc.)— (a) for “CE marking” in both places substitute “UK marking”; (b) in paragraph (8)(a)(i), after “essential requirement” insert “, a general safety and performance requirement”; (c) in paragraph (8)(a)(ii), omit “set out in the Medical Devices Directives”; (d) in paragraph (8)(a)(ii)(aa), for “his authorised representative” substitute “their UK responsible person”.

Amendment of regulation 9(5)

52

In regulation 9(5) after sub-paragraph (ii) insert—

(iii) in sub-paragraph (c) omit “and, where applicable any relevant provision of the Medical Devices Directives”.

Insertion of regulation 9(6A)

53

After regulation 9(6) insert—

(6A) In regulation 64 (notification of decisions etc)— (a) in paragraph (1)(c), for “him or his authorised representative” substitute “the applicant or the applicant’s UK responsible person”; (b) in paragraph (2)— (i) for “a UK notified body” substitute “an approved body”; (ii) for “his authorised representative” substitute “their UK responsible person”.

Omission of regulation 10

54

Omit regulation 10.

Omission of regulation 11

55

Omit regulation 11.

Substitution of Schedule 2A as inserted by regulation 12

56

For Schedule 2A as inserted by regulation 12 substitute—