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The Medical Devices Regulations 2002

Type Statutory-Instrument

Publication 2002-05-20

Last updated 2026-04-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(e) in Section 10.3 for “the provisions of Council Directive 80/181/EEC” substitute “the Units of Measurement Regulations 1986”;

(f) in Section 13.3—

(i) in point (a) —

(aa) for the first two references to “the Community” substitute “Great Britain”;

(bb) for the third reference to “the Community” substitute “the United Kingdom”;

(cc) for “the authorised representative” substitute “the UK responsible person (where appointed in accordance with regulation 7A of the Regulations)”;

(ii) in point (f) omit the second sentence;

(iii) in point (n) omit “in the case of a device within the meaning of Article 1(4a),”.

13

In Annex II—

(a) in the title omit “EC”;

(b) for each reference to “the notified body” substitute “the approved body”;

(d) in Section 2—

(i) omit “EC”;

(ii) for “this Directive” substitute “the Regulations”;

(iii) for “CE marking” substitute “UK marking”;

(iv) omit the words “in accordance with Article 17”;

(da) in Section 3.1—

(i) in the first sentence, for “a notified body” substitute “an approved body”;

(ii) for “other notified body” substitute “other approved body”;

(iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv) omit the seventh indent;

(e) in Section 3.2—

(i) in the first paragraph for “this Directive” substitute “the Regulations”

(ii) in point (c)—

(aa) for “Article 5” substitute “regulation 3A of the Regulations”;

(bb) for “Commission Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;

(f) for Section 3.3 substitute—

(3.3) The approved body must audit the quality system to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to these requirements. The assessment team must include at least one member with past experience of assessments of the technology concerned. The assessment procedure must include an assessment, on a representative basis, of the documentation of the design of the product concerned, an inspection on the manufacturer’s premises and, in duly substantiated cases, on the premises of the manufacturer’s suppliers and/or subcontractors to inspect the manufacturing processes. The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.

(g) for Section 3.4 substitute—

(3.4) The manufacturer must inform the approved body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The approved body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in Section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.

(h) in Section 4.2, for “this Directive” substitute “the Regulations”;

(i) for Section 4.3 substitute—

(4.3) The approved body must examine the application and, where the product complies with the relevant provisions of the Regulations, must issue the applicant with a design certificate. The approved body may require the application to be supplemented by further tests or proof so that compliance with the requirement of the Regulations may be evaluated. The certificate must contain conclusions of the examination, the conditions of its validity, the data needed for identification of the approved design and, where appropriate, a description of the intended use of the product. In the case of devices referred to in Annex 1, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body will give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State. In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State.

(j) in Section 4.4, omit each reference to “EC”;

(k) in Section 6.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(l) in Section 7.1 for “Article 11(2) and (3)” substitute “regulation 13(2) and (3) of the Regulations”;

(m) in Section 7.2 omit “for compliance with the provisions of this Directive”;

(n) in Section 7.3 omit “for compliance with the provisions of this Directive”;

(o) in Section 7.4 —

(i) for “this Directive” substitute “the Regulations”;

(ii) for “the competent authority” substitute “the Secretary of State”;

(p) for Section 8, substitute—

(8) Application to the devices incorporating a human blood derivative Upon completing the manufacture of each batch of devices incorporating a human blood derivative, the manufacturer shall inform the approved body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.

14

In Annex III—

(a) for each reference to “EC type-examination” (including in the title), substitute “type-examination”;

(b) in Section 1—

(i) for “a notified body” substitute “an approved body”;

(ii) for “this Directive” substitute “the Regulations”;

(i) in the first indent,—

(aa) for “authorized representative” substitute “UK responsible person” ;

(bb) for “the representative” substitute “the UK responsible person”;

(ii) in the second indent, for the second and third sentences substitute—

The applicant must provide samples at the request of the approved body.

(iii) in the third indent, for “notified” substitute “approved”;

(d) in Section 3—

(i) for each reference to “Article 5” substitute “regulation 3A of these Regulations”;

(ii) for “Directive 2003/32/EC” substitute “Commission Regulation 722/2012”;

(e) for Sections 4 and 5 substitute—

(4) The approved body must— (4.1) examine and assess the documentation, verify that the type has been manufactured in accordance with that documentation; it must also record the items which have been designed in accordance with the applicable provisions of the standards referred to in regulation 3A of the Regulations, as well as the items for which the design is not based on the relevant provisions of the said standards; (4.2) carry out or arrange for the appropriate inspections and the tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the Regulations where the standards referred to in regulation 3A of the Regulations have not been applied; if the device is to be connected to another device or other devices in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device having the characteristics specified by the manufacturer; (4.3) carry out or arrange for the appropriate inspections and the tests necessary to verify whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied; (4.4) agree with the applicant on the place where the necessary inspections and tests will be carried out. (5) Where the type meets the provisions of the Regulations, the approved body must issue a type-examination certificate to the applicant. The certificate must contain the name and address of the manufacturer, the conclusions of the inspection, the conditions under which the certificate is valid and the information necessary for identification of the type approved. The relevant parts of the documentation must be annexed to the certificate and a copy kept by the approved body. In the case of devices referred to in Annex I, Section 7.4, second paragraph, the approved body must, as regards the aspects referred to in that Section, consult the Secretary of State before taking the decision. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The scientific opinion of the Secretary of State must be included in the documentation concerning the device. The approved body must give due consideration to the views expressed in this consultation when making its decision. It must convey its final decision to the Secretary of State. In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the Secretary of State must be included in the documentation concerning the device. The opinion of the Secretary of State must be drawn up within 210 days after receipt of valid documentation. The approved body will give due consideration to the opinion of the Secretary of State when making its decision. The approved body may not deliver the certificate if the Secretary of State’s decision is unfavorable. It must convey its final decision to the Secretary of State. In the case of devices manufactured utilizing tissues of animal origin referred to in Commission Regulation 722/2012, the approved body must follow the procedures referred to in that Regulation.

(f) in Section 6—

(i) for each reference to “notified body” substitute “approved body”;

(ii) omit each reference to “EC”;

(g) for Section 7.2 substitute—

(7.2) An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.

(h) in Section 7.3 —

(i) for “authorised representative” substitute “UK responsible person”;

(ii) omit “EC”.

15

In Annex IV—

(a) omit “EC” (including in the title) each time it occurs;

(b) for both references to “this Directive” substitute “the Regulations”;

(d) in Section 1 for “authorized representative” substitute “UK responsible person”;

(e) in Section 2—

(i) for “CE marking” substitute “UK marking”;

(ii) for “Article 17” substitute “regulation 10 of the Regulations”;

(f) omit Section 3;

(g) for Sections 4 to 6 substitute—

(4) The approved body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Regulations either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides. The aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility. (5) Verification by examination and testing of every product (5.1) Every product must be examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations must be carried out in order to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them. (5.2) The approved body must affix, or have affixed its identification number to each approved product and must draw up a written certificate of conformity relating to the tests carried out. (6) Statistical verification (6.1) The manufacturer must present the manufactured products in the form of homogeneous batches. (6.2) A random sample must be taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standards referred to in regulation 3A of the Regulations or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the type-examination certificate and with the requirements of the Regulations which apply to them in order to determine whether to accept or reject the batch. (6.3) Statistical control of products will be based on attributes and/or variables entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the designated standards referred to in regulation 3A of the Regulations, taking account of the specific nature of the product categories in question. (6.4) If the batch is accepted, the approved body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform. If a batch is rejected, the approved body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the approved body may suspend the statistical verification. The manufacturer may, on the responsibility of the approved body, affix the approved body’s identification number during the manufacturing process.

(h) in Section 7—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 8, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;

(zj) in Section 8.2 for “notified body” substitute “approved body”;

(j) in Section 9—

(i) for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

(ia) for “notified body” substitute “approved body”;

(ii) for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012”.

16

In Annex V—

(a) for “notified body” each time it occurs substitute “approved body”;

(b) omit “EC” each time it occurs, including in the title;

(d) in Section 2—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “CE marking in accordance with Article 17” substitute “UK marking”;

(e) omit the eighth indent of Section 3.1;

(f) in Section 3.3, for the first sentence substitute—

The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.

(g) in Section 3.4, for the last two paragraphs substitute—

The proposed changes must be evaluated by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.

(h) in Section 5.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 6 for each reference to “this Directive” substitute “the Regulations”;

(j) in Section 6.3, for “competent authority” substitute “Secretary of State”;

(k) in Section 7—

(i) for the words “referred to in Article 1(4a)” substitute “which incorporate a substance derived from human blood or human plasma”;

(ii) for the words from “a State laboratory” to the end of that Section, substitute “a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

17

In Annex VI—

(a) omit “EC” each time it occurs including in the title;

(b) for “the notified body” each time it occurs substitute “the approved body”;

(d) in Section 2—

(i) for “CE marking in accordance with Article 17” substitute “UK marking”;

(ii) for “CE marking must” substitute “UK marking must”;

(e) in Section 3.1–

(i) for “a notified body” substitute “an approved body”;

(ii) for “other notified body” substitute “other approved body”;

(iii) omit the eighth indent;

(f) in Section 3.3, for the first sentence substitute—

The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2.

(g) in Section 3.4, for the second paragraph substitute—

The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.

(ga) in Section 4.4 for “Article 5” substitute “regulation 3A of the Regulations”;

(h) in Section 5.1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “national authorities” substitute “Secretary of State”;

(i) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”;

(j) in Section 6.3, for “competent authority” substitute “Secretary of State”.

(k) in Section 6.4 for “notified body” substitute “approved body”.

18

In Annex VII—

(a) in the title and in Section 1, omit “EC”;

(b) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(i) “his authorised representative” substitute “the manufacturer’s UK responsible person”;

(ii) “national authorities” substitute “Secretary of State”;

(d) in Section 3—

(i) in the opening paragraph for “the Directive” substitute “the Regulations”;

(ii) in the fourth indent—

(aa) for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(bb) for “of the Directive” substitute “in Annex I”;

(e) omit Section 4;

(f) in Section 5, for “the intervention by the notified body” substitute “the intervention by the approved body”;

(g) in Section 6, in the opening paragraph, for “Article 11(2)” substitute “regulation 13(2) of the Regulations”.

19

In Annex VIII—

(a) in Section 1, for “authorized representative” substitute “UK responsible person”;

(b) in Section 2.2 in the seventh indent for “Directive 2003/32/EC” substitute “Regulation 722/2012”;

(d) in Sections 3.1 and 3.2, for “this Directive” each time it occurs substitute “the Regulations”;

(e) in Section 3.2—

(i) in the fourth indent, for “Article 5” in both places it occurs substitute “regulation 3A of the Regulations”;

(ii) in the sixth indent, for “Directive 2003/32/EC” substitute “Regulation 722/2012”;

(f) omit Section 5.

20

In Annex IX for “this Directive” each time it occurs substitute “the Regulations”.

21

In Annex X—

(a) in Section 1.1 for “harmonised standards” substitute “designated standards”;

(b) in Section 2.3.5 for the words from “all competent authorities of the Member States” to the end substitute “the Secretary of State”.

22

In Annex X1—

(a) in the title, for “notified bodies” substitute “approved bodies”;

(b) for the words “notified body” each time they occur substitute “approved body”;

(d) in Section 2, for “national authorities” substitute “Secretary of State”;

(e) in Section 3, for “this Directive” substitute “the Regulations”;

(f) in Section 6, omit the words from “, unless liability” to the end of that Section;

(g) in Section 7, omit the words from “(except vis a visthe competent administrative authorities” to the end.

23

Omit Annex XII.

PART 3 — Modification of Annexes to Directive 98/79

24

(1) The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 25 to 33.

(2) In this Part any reference to “the Regulations” is a reference to the Medical Devices Regulations 2002.

25

In Annex 1—

(a) in Section 3 in part A, for “Article 1(2)(b)” substitute “regulation 2(1) of the Regulations”;

(b) in Section 4.2 in part B, for “Council Directive 80/181/EEC of 20th December 1979” substitute “the Units of Measurement Regulations 1986”;

(d) in Section 8.2 in part B, for “harmonised standards” substitute “designated standards”;

(e) in Section 8.3 in part B —

(i) in the first sentence omit “of Directive 67/548/EEC and Directive 88/379/EEC”;

(ii) in the second sentence omit “by those Directives”;

(iii) omit the words from “The provisions of” to the end;

(f) in Section 8.4 in point (a), for the sentence beginning “For devices imported”, substitute—

Where the manufacturer does not have a registered place of business in the United Kingdom the label, the outer packaging or instructions for use shall contain in addition the name and address of the UK responsible person.

26

In Annex III—

(a) in the title and in Section 1, omit “EC”;

(b) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(iii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(d) in Section 3, in the sixth indent, for “Article 5” in both places substitute “regulation 3A of the Regulations”;

(e) omit Section 5;

(f) in Section 6, for “a notified body” substitute “an approved body”;

(g) in Section 6.2—

(i) for “notified body”, both times those words occur, substitute “approved body”;

(ii) in the first sentence, for “this Directive” substitute “the Regulations”;

(iii) in the second sentence omit “of the Directive”;

(iv) for “an EC” substitute “a” ;

(h) in Section 6.3—

(i) for “notified body” in both places substitute “approved body”;

(ii) omit each reference to “EC”;

(iii) for “the Directive” substitute “the Regulations”.

27

In Annex IV—

(a) in the title, omit “EC”;

(b) for each reference to “this Directive” and “the Directive” substitute “the Regulations”;

(d) in Section 3.1—

(i) for “of his quality system with a notified body” substitute “of its quality system with an approved body”;

(ii) in the third indent for “notified body” substitute “approved body”;

(iii) omit the final indent;

(e) in Section 3.3 for the first paragraph substitute—

The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. It must presume that quality systems which implement the relevant designated standards conform to the requirements.

(f) in Section 3.4, in both paragraphs, for “notified body” substitute “approved body”;

(g) in Section 4.1 for “notified body” substitute “approved body”;

(h) in Section 4.3—

(i) for “notified body” both times those words occur substitute “approved body”;

(ii) for “an EC” substitute “a”;

(i) in Section 4.4—

(i) for “notified body” both times those words occur substitute “approved body”;

(ii) omit each reference to “EC”;

(j) in Section 4.5, for “notified body” both times those words occur substitute “approved body”;

(k) in Sections 5 and 6 for “notified body” each time those words occur substitute “approved body”.

28

In Annex V—

(a) in the title, omit “EC” ;

(b) in Section 1—

(i) for “EC type-examination” substitute “Type-examination”;

(ii) for “a notified body” substitute “an approved body”;

(iii) for “this Directive” substitute “the Regulations”;

(i) in the first paragraph—

(aa) omit “EC”;

(bb) for “his authorised representative” substitute “its UK responsible person”;

(cc) for “a notified body” substitute “an approved body”;

(ii) in the first indent—

(aa) for “authorised representative” substitute “UK responsible person”;

(bb) for “the representative” substitute “the UK responsible person”;

(iii) in the second indent for “this Directive” substitute “the Regulations”;

(iv) in the second and third indents for “notified body” each time those words occur substitute “approved body”;

(d) in Section 4—

(i) for “notified body shall” substitute “approved body must”;

(ii) for both references to “Article 5” substitute “regulation 3A of the Regulations”;

(iii) for “this Directive” substitute “the Regulations”;

(e) in Section 5—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “notified body” in both places substitute “approved body”;

(iii) for “an EC” substitute “a”;

(f) in Section 6—

(i) for “notified body” each time it occurs substitute “approved body”;

(ii) omit “EC” each time it occurs;

(iii) for “the Directive” substitute “the Regulations”;

(g) for Section 7, substitute—

(7) An approved body must cooperate with other approved bodies with regard to making available copies of the type-examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other approved bodies with the consent of the manufacturer.

29

In Annex VI—

(a) in the title omit “EC”;

(b) in Section 1—

(i) for “EC verification” substitute “Verification”;

(ii) for “authorised representative” substitute “UK responsible person”;

(iii) for “EC type-examination” substitute “type-examination”;

(iv) for “this Directive” substitute “the Regulations”;

(i) for “EC type-examination” in both places substitute “type-examination”;

(ii) for “the Directive” substitute “the Regulations”;

(iii) for “this Directive” substitute “the Regulations”;

(d) in Section 2.2 for “notified body” substitute “approved body”;

(da) omit Section 3;

(e) in Section 4—

(i) for “notified body” in both places substitute “approved body”;

(ii) for “the Directive” substitute “the Regulations”;

(f) in Section 5.1—

(i) for “Article 5” substitute “regulation 3A of the Regulations”;

(ii) omit “EC”;

(iii) for “the Directive” substitute “the Regulations”;

(g) in Section 5.2 for “notified body” substitute “approved body”;

(h) in Section 6.2—

(i) for “Article 5” substitute “regulation 3A of the Regulations”;

(ii) omit “EC”;

(iii) for “the Directive” substitute “the Regulations”;

(i) in Section 6.3 for “the harmonised standards referred to in Article 5” substitute “the designated standards referred to in regulation 3A of the Regulations”;

(j) in Section 6.4—

(i) for the first two paragraphs, substitute—

Where the approved body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.

(ii) in the third paragraph, for “notified body”, in both places, substitute “approved body”.

30

In Annex VII—

(a) in the title and in Section 2, omit “EC”;

(b) in Section 2—

(i) for “this Directive” substitute “the Regulations”;

(ii) for “CE marking in accordance with Article 16” substitute “UK marking in accordance with regulation 36 of the Regulations”;

(i) for “a notified body” substitute “an approved body”;

(ii) for “EC type-examination” substitute “type-examination”;

(d) in Section 3.2, for “EC type-examination” substitute “type-examination”;

(e) in Section 3.3 for the first two sentences substitute—

The quality system must be audited by the approved body to determine whether it meets the requirements referred to in Section 3.2. The approved body must presume that quality systems which implement the relevant designated standards conform to the requirements.

(f) in Section 3.4—

(i) for “notified body” substitute “approved body”;

(ii) for the first sentence of the second paragraph substitute “The proposed changes must be assessed by the approved body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.”;

(g) in Sections 5.1 and 5.2, for each reference to “notified body” substitute “approved body”.

31

In Annex VIII—

(a) in Section 1—

(i) for “authorised representative” substitute “UK responsible person”;

(ii) for “this Directive” substitute “the Regulations”;

(b) in Section 2, for “the Directive” substitute “the Regulations”;

(i) for “competent national authorities” substitute “Secretary of State”;

(ii) for “this Directive” substitute “the Regulations”.

32

In Annex IX—

(a) in the title, for “notified bodies” substitute “approved bodies”;

(b) for each reference to “notified body” substitute “approved body”;

(d) in Section 2—

(i) for “the Directive” substitute “the Regulations”;

(ii) for “national authorities” substitute “Secretary of State”;

(iii) for “this Directive” substitute “the Regulations”;

(e) in Section 3—

(i) for “has been notified” substitute “has been designated”;

(ii) for “this Directive” substitute “the Regulations”;

(f) in Section 6, omit the words from “unless liability” to the end;

(g) in Section 7, omit the words from “(except vis à vis the competent administrative authorities” to the end.

33

Omit Annex X.

Registration of persons placing general medical devices on the market

7A

(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a) is established in Great Britain; and

(b) has complied with paragraph (2).

(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

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) 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 approved body of that termination.

(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.

Essential requirements for general medical devices

Determining compliance of general medical devices with relevant essential requirements

UK marking of general medical devices

UK(NI) indication: general medical devices

UK marking of general medical devices that come within the scope of this Part and other legislation

Exemptions from regulations 8 and 10

Procedures for affixing a UK marking to general medical devices

Procedures for systems and procedure packs, and for devices to be sterilised before use

Procedures for custom-made general medical devices

Procedures for general medical devices for clinical investigations

Manufacturers etc. and conformity assessment procedures for general medical devices

Approved bodies and the conformity assessment procedures for general medical devices

Registration of persons placing general medical devices on the market

Additional requirements relating to use of animal tissues

Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42

Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745

21A

(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a) is established in Great Britain; and

(b) has complied with paragraph (2).

(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

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) 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 to 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 approved body of that termination.

(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.

Registration of persons placing active implantable medical devices on the market

Requirement to appoint a UK responsible person for active implantable medical devices

Essential requirements for active implantable medical devices

Determining compliance of active implantable medical devices with relevant essential requirements

UK marking of active implantable medical devices

UK(NI) indication: active implantable medical devices

UK marking of active implantable medical devices that come within the scope of this Part and other legislation

Exemptions from regulations 22 and 24

Procedures for affixing a UK marking to active implantable medical devices

Procedures for custom-made active implantable medical devices

Procedures for active implantable medical devices for clinical investigations

Manufacturers etc. and conformity assessment procedures for active implantable medical devices

Obligations in Part III which are met by complying with obligations in Directive 90/385

Approved bodies and the conformity assessment procedures for active implantable medical devices

Registration etc. of persons placing in vitro diagnostic medical devices on the market

33A

(1) No person may place a relevant device on the market in accordance with this Part unless that person—

(a) is established in Great Britain; and

(b) has complied with paragraph (2).

(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

(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

(3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) 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 approved body of that termination.

(4) 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.

(5) 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.

(6) In this regulation 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.

(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.

Essential requirements for in vitro diagnostic medical devices

Determining compliance of in vitro diagnostic medical devices with relevant essential requirements

UK marking of in vitro diagnostic medical devices

UK(NI) indication: in vitro diagnostic medical devices

UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation

In vitro diagnostic medical devices not ready for use

Exemptions from regulations 34, 36 and 38

Procedures for affixing a UK marking to in vitro diagnostic medical devices

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices

Devices for performance evaluation

Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation

Obligations in Part IV which are met by complying with obligations in Directive 98/79

Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

3ZA

(1) Subject to paragraph (2), Parts 2 to 7 only apply in Northern Ireland for the purpose of regulating qualifying devices.

(2) The following provisions continue to apply in Northern Ireland in accordance with this paragraph ...—

(a) for the purposes of the registration of medical devices (whether or not they are qualifying devices) and persons placing medical devices on the market in Northern Ireland—

(i) regulation 19 (registration of persons placing general medical devices on the market),

(ii) regulation 21B (registration of persons placing active implantable medical devices on the market),

(iii) regulation 44 (registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation), and

(iv) regulation 53 (fees in connection with the registration of devices and changes to registration details),

only apply until the date which is 24 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745;

(aa) regulations 34A to 34D, 38A to 38C, 39A, 56A, 59 and 61 continue to apply in relation to coronavirus test devices whether or not they are qualifying devices;

(b) Parts 5 to 7 also apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.

(3) For the purposes of this regulation, a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745 or Article 110 of Regulation (EU) 2017/746—

(a) it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of Directive 90/385, Directive 93/42 or Directive 98/79, rather than Regulation (EU) 2017/745 or Regulation (EU) 2017/746; and

(b) it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2 ... to 7.

Designated standard

Confidentiality

Transitional provisions

Transitional provisions for hip, knee and shoulder replacements

Revocations, transitional and saving provisions in respect of the new national registration requirements

Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date

Revocation of Commission Decision 2010/227

Revocation of Regulation (EU) No 207/2012 on 26th May 2025 and its effect before that date

Revocation of Regulation (EU) No 722/2012 on 26th May 2025

Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date

Revocation of Regulation (EU) No 2017/2185 and saving provision

The classification criteria in Directives 2003/12 and 2005/50

Revocation of Regulation (EU) 2017/745

Revocation of Regulation (EU) 2017/746

References in other legislation to Directives 90/385, 93/42 and 98/79

Approval requirement for coronavirus test devices

34A

(1) Subject to regulations 34B to 34D, 39(1) and 39A, no person other than the Secretary of State may place on the market or put into service a coronavirus test device, unless—

(a) the Secretary of State has approved it in accordance with regulation 38A(5); and

(b) the approval remains valid in accordance with regulation 38A(6).

(2) Subject to regulations 34B to 34D, 39(1) and 39A, no person other than the Secretary of State may supply a coronavirus test device—

(a) if that supply is also a placing on the market or putting into service of that device; or

(b) in circumstances where that device has been placed on the market or put into service,

unless the Secretary of State has approved it in accordance with regulation 38A(5) and the approval remains valid in accordance with regulation 38A(6).

(3) The requirements in paragraphs (1) and (2) are without prejudice to the other requirements of this Part.

Public sector use of coronavirus test devices

34B

(1) Regulation 34A(1) does not apply in relation to a coronavirus test device that is placed on the market or put into service only for use by—

(a) the Secretary of State;

(b) a devolved public health body; or

(2) Regulation 34A(2) does not apply in relation to a coronavirus test device that is supplied to—

(a) the Secretary of State;

(b) a devolved public health body; or

(3) In this regulation—

“a devolved public health body” is—in Wales, Welsh Ministers or Public Health Wales National Health Service Trust;in Scotland, Scottish Ministers;in Northern Ireland, the Department of Health in Northern Ireland;

“an existing contract” is a contract entered into before the coming into force of regulation 34A;

“a health service body” is—an NHS body as defined in section 275 of the National Health Service Act 2006 or in section 206 of the National Health Service (Wales) Act 2006;a body listed in section 17A(2)(a) to (c) or (e) of the National Health Service (Scotland) Act 1978; ora health and social care body as defined in section 1(5)(a) to (e) of the Health and Social Care (Reform) Act (Northern Ireland) 2009.

Transitional provisions for coronavirus test devices

34C

(1) The requirements in regulation 34A do not apply in respect of any period before 1st September 2021.

(2) A person may place on the market, put into service or supply a coronavirus test device from 1st September 2021 until the end of 31st October 2021 if—

(a) that person has made an application to the Secretary of State in respect of that device, in accordance with regulation 38A; or

(b) that person is not—

(i) the manufacturer of the device,

(ii) a person acting as the manufacturer’s UK responsible person appointed for the purposes of regulation 33A or under regulation 44A, or

(iii) a person acting as the manufacturer’s authorised representative in Northern Ireland in accordance with regulation 44.

Determining compliance of in vitro diagnostic medical devices with relevant essential requirements

UK marking of in vitro diagnostic medical devices

UK(NI) indication: in vitro diagnostic medical devices

UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation

In vitro diagnostic medical devices not ready for use

Applications for approval of coronavirus test devices

38A

(1) A person may make an application to the Secretary of State under this regulation for approval of a coronavirus test device.

(2) An application must include such information as the Secretary of State may require for the purposes of exercising their functions under—

(a) paragraph (5); and

(b) regulation 38C.

(3) An application must be made through the gov.uk website.

(4) The Secretary of State may treat an application made before the coming into force of this regulation as an application made under this regulation, if it meets the requirements of paragraph (2).

(5) The Secretary of State must approve a coronavirus test device if the Secretary of State is satisfied on the basis of the information contained in the application that the coronavirus test device meets the requirements of regulation 38B.

(6) An approval granted under paragraph (5) is valid for a period of 5 years, beginning with the day on which it is granted.

(7) Nothing in this regulation shall be taken to prevent—

(a) the Secretary of State;

(b) a weights and measures authority in Great Britain; or

from exercising a duty under regulation 61 to enforce these Regulations.

Performance requirements for coronavirus test devices

38B

(1) The requirements that a coronavirus test device must meet for the purposes of regulation 38A(5) are set out in paragraphs (2) to (6).

(2) A coronavirus test device must be able to be put into service in accordance with this Part.

(3) A coronavirus test device that is an antigen test must have—

(a) a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 60%;

(b) a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.

(4) A coronavirus test device that is a direct molecular test must have—

(a) a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 70%;

(b) a level of specificity, using a 95% two-sided confidence interval, that is entirely above 93%.

(5) A coronavirus test device that is an extracted molecular test must have—

(a) a level of sensitivity, using a 95% two-sided confidence interval, that is entirely above 93%;

(b) a level of specificity, using a 95% two-sided confidence interval, that is entirely above 97%.

(6) Where a coronavirus test device is also intended to detect the presence of anything other than a viral antigen or viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the requirements in paragraphs (2) to (5) apply only in relation to its performance in detecting the presence of that viral antigen or viral ribonucleic acid (RNA).

(7) In this regulation and in regulation 38C—

“antigen test” means an in vitro diagnostic medical device for the detection of the presence of a viral antigen specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

“direct molecular test” means an in vitro diagnostic medical device which—is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), anddoes not use a preliminary step of purification and concentration;

“extracted molecular test” means an in vitro diagnostic medical device which—is for the detection of the presence of viral ribonucleic acid (RNA) specific to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), anduses a preliminary step of purification and concentration;

“sensitivity”, in relation to a coronavirus test device, means the proportion of true positives that are correctly identified by the test, calculated using the equation—$Sensitivity=True PositivesTrue Positives+False Negatives$

“specificity”, in relation to a coronavirus test device, means the proportion of true negatives that are correctly identified by the test, calculated using the equation—$Specificity=True NegativesTrue Negatives+False Positives$

Register of approved coronavirus test devices

38C

(1) The Secretary of State must establish a register of coronavirus test devices which the Secretary of State has approved in accordance with regulation 38A.

(2) The Secretary of State must publish the register on the gov.uk website.

(3) The register must contain the following information in respect of each coronavirus test device—

(a) the name and address of the registered place of business of the person who made the application under regulation 38A;

(b) if the person who made the application was not the manufacturer, the name and address of the registered place of business of the manufacturer;

(d) the name and address of the registered place of business of the UK responsible person or the manufacturer’s authorised representative having a registered place of business in Northern Ireland, if there is one in respect of the device;

(e) the name and description of the coronavirus test device;

(f) the date and version number of the instructions for use included in the application;

(g) whether the coronavirus test device is an antigen test, a direct molecular test, or an extracted molecular test;

(h) the date on which the coronavirus test device was approved in accordance with regulation 38A and the date on which that approval ceases to be valid.

(4) The register may contain such other information relating to the coronavirus test device and its intended use as the Secretary of State considers appropriate.

Exemptions from this Part

Exemptions for coronavirus test devices

39A

(1) Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—

(a) has decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); and

(b) has not withdrawn that permission.

(2) The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.

(3) If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.

(4) The Secretary of State may withdraw or amend a protocol published under paragraph (2).

Procedures for affixing a UK marking to in vitro diagnostic medical devices

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices

Devices for performance evaluation

Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation

Obligations in Part IV which are met by complying with obligations in Directive 98/79

Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

Fees in connection with approval of coronavirus test devices

56A

(1) A person who makes an application to the Secretary of State under regulation 38A(1) must pay to the Secretary of State a fee of—

(a) £14,000; or

(b) if the person is a small or medium-sized enterprise, £6,200.

(2) Where the Secretary of State, in accordance with regulation 38A(4), treats an application made before the coming into force of regulation 38A as an application made under that regulation, a payment made in respect of that application before the coming into force of this regulation must be treated as—

(a) a payment meeting the requirements of paragraph (1), if that payment would have met those requirements after their coming into force; or

(b) a payment contributing in part to the payment required by paragraph (1), if that payment would not have met those requirements after their coming into force.

(3) In this regulation—

(a) a person is a small or medium-sized enterprise if it and persons associated with it employ no more than 250 individuals in total; and

(b) “persons associated with it” has the same meaning as in section 882 of the Corporation Tax Act 2010.

Unpaid fees

Waivers, reductions and refunds

Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025

Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

56B

(1) Subject to paragraph (2), the fee payable by an approved body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulation 56C.

(2) No fee is payable if it is the first time the Secretary of State has been consulted by any approved body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.

Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

56C

(1) Subject to regulation 56B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—

(a) £4,953 if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b) £11,543 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

(2) Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—

(a) £980 if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b) £2,668 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

(3) In relation to a device which incorporates a new medicinal substance, the fee is—

(a) £50,644 for a consultation; and

(b) £12,574 for a further consultation.

(4) Where an approved body consults the Secretary of State in relation to more than one device at the same time and those devices—

(a) are of similar construction and are designed to perform similar functions;

(b) incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.

(5) Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which an approved body consults the Secretary of State.

Fees payable in connection with pre-consultation meetings

56D

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Unpaid fees

Waivers, reductions and refunds

Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107

34D

Regulation 34A does not apply in Northern Ireland—

(a) in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746 and the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107;

(b) after 24 July 2024, in relation to a coronavirus test device that is in conformity with Regulation (EU) 2017/746.

Determining compliance of in vitro diagnostic medical devices with relevant essential requirements

UK marking of in vitro diagnostic medical devices

UK(NI) indication: in vitro diagnostic medical devices

UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation

In vitro diagnostic medical devices not ready for use

Applications for approval of coronavirus test devices

Performance requirements for coronavirus test devices

Register of approved coronavirus test devices

Exemptions from this Part

Exemptions for coronavirus test devices

Procedures for affixing a UK marking to in vitro diagnostic medical devices

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices

Devices for performance evaluation

Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation

Obligations in Part IV which are met by complying with obligations in Directive 98/79

Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746

PART 4A — Post-market surveillance requirements

Interpretation of Part 4A

44ZC

In this Part—

“corrective action” means action taken in order to—eliminate the cause of a potential or actual non-conformity of a device, orreduce any other risk posed by a device,that has already been manufactured and may include recalling the device, withdrawing it from the market, and taking it out of service;

“field safety corrective action” means a corrective action taken by the manufacturer to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service;

“incident” means in relation to a device that has been placed on the market or put into service—a malfunction or deterioration in the characteristics or performance of the device when used in accordance with the instructions for use,a side-effect that has a negative impact on—the health of an individual,patient management, orpublic health,an inadequacy in the design of the device, including an ergonomic feature, to enable the user to use the device safely and as intended by the manufacturer,an inadequacy in the information supplied with the device by the manufacturer to enable the user to use the device safely and as intended by the manufacturer, oran erroneous result provided by a diagnostic medical device, which informs a decision in relation to medical treatment;

“lifetime of a device” means the shelf life of a device (if there is one) plus the period that the manufacturer expects that device to perform as intended;

“PMS period” means the period—beginning with the day on which the first device of a device model is put into service by the manufacturer or placed on the market, whichever is sooner, andending with the end of the lifetime of the last device of that device model that is put into service by the manufacturer or placed on the market, whichever is later;

“post-market surveillance” means activities carried out by manufacturers to proactively collect and review experience gained from devices placed on the market or put into service for the purposes of identifying any need to apply corrective or preventive actions;

“preventive action” means action taken by the manufacturer before completion of the manufacturing phase in order to eliminate the cause of a potential non-conformity or reduce a potential risk that could be posed by the finished device;

“Regulation (EU) No 722/2012” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin, as it had effect in the EU on 25 May 2021;

“relevant device” means a device that is a “relevant device” for the purposes of Part 2, 3 or 4;

“relevant essential requirements” means—in relation to a device placed on the market in accordance with regulation 19B, the essential requirements set out in Annex I of Directive 93/42 and, where applicable, Regulation (EU) No 722/2012 which apply to it;in relation to a device placed on the market in accordance with regulation 19C, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/745 which apply to it;in relation to a device otherwise placed on the market or put into service in accordance with Part 2, the requirements referred to in regulation 8 (essential requirements for general medical devices) which apply to it;in relation to a device placed on the market in accordance with regulation 30A, the essential requirements set out in Annex I of Directive 90/385 and, where applicable, Regulation (EU) No 722/2012 which apply to it;in relation to a device otherwise placed on the market or put into service in accordance with Part 3, the requirements referred to in regulation 22 (essential requirements for active implantable medical devices) which apply to it;in relation to a device placed on the market in accordance with regulation 44ZA, the essential requirements set out in Annex I of Directive 98/79 which apply to it;in relation to a device placed on the market in accordance with regulation 44ZB, the general safety and performance requirements set out in Annex I of Regulation (EU) 2017/746 which apply to it;in relation to a device otherwise placed on the market or put into service in accordance with Part 4, the essential requirements referred to in regulation 34 (essential requirements for in vitro diagnostic medical devices) which apply to it;

“required risk analysis” means the analysis required to weigh the risks posed by a device against the intended performance and benefits for the purposes of confirming conformity with the relevant essential requirements;

“serious deterioration of any person’s state of health” means any of the following—life-threatening illness or injury;permanent impairment of a body structure or a body function;hospitalisation or prolongation of hospitalisation;medical treatment, including surgical intervention and self-administered treatment, that is required to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function;chronic disease;foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

“serious incident” means an incident that directly or indirectly led, might have led or might lead to any of the following—the death of any person;the serious deterioration of any person’s state of health;a serious public health threat;

“serious public health threat” means an event which could result in a risk—of death, serious illness, or serious deterioration of any person’s state of health,that affects a significant population, andthat requires prompt remedial action;

“similar device” means a device which—has the same or a similar intended purpose, andis based on the same or similar technology;

“system or procedure pack” has the same meaning as in regulation 5(1).

Scope of Part 4A

44ZD

(1) Subject to paragraphs (2) and (3), the requirements of this Part apply in respect of relevant devices that are—

(a) put into service by the manufacturer, or

(b) placed on the market,

in accordance with Parts 2, 3 or 4 on or after the date on which the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 come into force.

(2) The following regulations in this Part apply in respect of custom-made devices—

(a) regulation 44ZC (interpretation of Part 4A);

(b) regulation 44ZE (post-market surveillance system);

(d) regulation 44ZG (preventive and corrective actions);

(e) regulation 44ZH (initial reporting of serious incidents);

(f) regulation 44ZI (investigation and final reporting of serious incidents);

(g) regulation 44ZJ (field safety corrective actions and field safety notices);

(h) regulation 44ZO (reports received by the Secretary of State);

(i) regulation 44ZP (analysis of information received under Part 4A);

(j) regulation 44ZQ (retention of post-market surveillance documentation);

(k) regulation 44ZR (requests for post-market surveillance documentation).

(3) This Part does not apply to—

(a) devices intended for clinical investigation or performance evaluation;

(b) devices placed on the market or put into service in accordance with an authorisation issued by the Secretary of State under regulation 12(5), 26(3) or 39(2).

(4) In this Part, the relevant devices to which this Part applies are referred to as “devices”.

(5) In this regulation, “custom-made device” means a device within the meaning of that term as defined in regulation 5 or regulation 20.

Post-market surveillance system

44ZE

(1) The manufacturer must maintain a post-market surveillance system (“PMS system”) for each device that is placed on the market or put into service.

(2) The manufacturer must ensure the PMS system—

(a) is proportionate to the risk posed by the device;

(b) is appropriate to the type of device;

(c) includes the analysis of data relevant to the quality, performance and safety of the device throughout its lifetime, and a record of the manufacturer’s conclusions based on that analysis.

(3) The manufacturer must ensure that the PMS system is used throughout the PMS period to identify—

(a) preventive actions and corrective actions, including field safety corrective actions;

(b) trends in incidents, including those on which the manufacturer must report under regulation 44ZN (trend reporting);

(d) any impact on the post-market surveillance of other devices.

(4) The manufacturer must ensure that data gathered through the PMS system is used to update the following—

(a) for devices placed on the market or put into service in accordance with Part 2 or 3—

(i) the instructions for use and labelling of the device;

(ii) design and manufacturing information;

(iii) the required risk analysis;

(iv) the evaluation of clinical data referred to in regulations 9(2) and 23(2) for the purposes of confirming conformity with the relevant essential requirements;

(v) any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 2 or 3.

(b) for devices placed on the market or put into service in accordance with Part 4—

(i) the instructions for use and labelling of the device;

(ii) design and manufacturing information;

(iii) the required risk analysis;

(iv) any evaluation of performance evaluation data confirming conformity with the relevant essential requirements;

(v) any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 4.

(5) Paragraph (4) does not apply in respect of a device placed on the market in accordance with regulation 19B, 19C, 30A, 44ZA or 44ZB.

Post-market surveillance plan

44ZF

(1) The manufacturer must base the post-market surveillance system on a post-market surveillance plan (“PMS plan”) that complies with this regulation.

(2) A PMS plan must be—

(a) clear, organised and searchable, and

(b) maintained for the PMS period of the device model.

(3) A PMS plan must specify the lifetime of the device and must include—

(a) processes for the collection and assessment of the following information in relation to the device—

(i) information about serious incidents, other incidents and side-effects;

(ii) information about field safety corrective actions;

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