The Medical Devices Regulations 2002

PART IVU.K.In Vitro Diagnostic Medical Devices

Interpretation of Part IVE+W+S

32.—(1) In this Part F1...—

• “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

  (a)

  itself an in vitro diagnostic medical device;

  (b)

  an invasive sampling medical device; or

  (c)

  a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

• “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

• [F2“common technical specification” means a technical specification set out in the Annex to Commission Decision 2002/364/EC (as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act) for a relevant device referred to in a list in Annex II;]

• “device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and

• “relevant device” shall be construed in accordance with regulation 33(1);

(2) In this Part F1..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Interpretation of Part IVN.I.

32.—(1) In this Part F62...—

• “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

  (a)

  itself an in vitro diagnostic medical device;

  (b)

  an invasive sampling medical device; or

  (c)

  a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

• “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

• “common technical specification” means a technical specification for a relevant device referred to in a list in Annex II which has been adopted in accordance with the procedure set out in article 7(2) and published in the Official Journal of the [F63European Union];

• “device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and

• “relevant device” shall be construed in accordance with regulation 33(1);

(2) In this Part F62..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Scope of Part IVU.K.

33.—(1) The requirements of this Part in respect of relevant devices apply in respect ofin vitro diagnostic medical devices [F3(including coronavirus test devices)] and accessories to such devices, except for—

(a)products manufactured and used within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; [F4and]

(b)[F5devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii)the manufacturer chooses to follow the set of arrangements in the other Directive.]

(2) The requirements of this Part in respect of devices for performance evaluation do not apply in respect of—

(a)products manufactured and used only within the same health institution and either on the premises of their manufacture or on premises in the immediate vicinity without having been transferred to another legal entity; [F6and]

(b)[F7devices that come within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and

(i)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and

(ii)the manufacturer chooses to follow the set of arrangements in the other Directive.]

[F8Registration etc. of persons placing in vitro diagnostic medical devices on the marketU.K.

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

(c)that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

(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 devicesU.K.

34.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex I which apply to it.

(2) Subject to regulation 39, no person shall supply a relevant 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 that device meets those essential requirements set out in Annex I which apply to it.

[F9Approval requirement for coronavirus test devicesU.K.

34A.—(1) Subject to regulations [F1034B 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 [F1134B 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 devicesU.K.

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

(c)a health service body supplied pursuant to an existing contract.

(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

(c)a health service body pursuant to an existing contract.

(3) In this regulation—

“a devolved public health body” is—

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

“a health service body” is—

Transitional provisions for coronavirus test devicesU.K.

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.]

[F12Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107U.K.

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 requirementsE+W+S

35.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English F13... .

(3) A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant [F14designated standard].

(4) A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.

Determining compliance of in vitro diagnostic medical devices with relevant essential requirementsN.I.

35.—(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(2) In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English if the device may reach a final user in [F64Northern Ireland], unless—

(a)the Secretary of State, to the extent that Directive 98/79 allows him to do so, has authorised the use of another Community language or more than one other Community language; or

(b)the relevant device is a device for self-testing, in which case the instructions for use and the label must include a translation into the official language of any member State of the Community in which the device reaches a final user.

(3) A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant national standard.

(4) A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.

[F15UK marking] of in vitro diagnostic medical devicesE+W+S

36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a [F16UK marking] which—

(a)meets the requirements set out in [F17Annex 2 of Regulation 765/2008];

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F18approved body] or conformity assessment body identification number for that device.

(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a [F16UK marking] which—

(a)meets the requirements set out in [F17Annex 2 of Regulation 765/2008];

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant [F18approved body] or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a [F16UK marking], meeting the requirements set out in [F17Annex 2 of Regulation 765/2008], appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that [F16UK marking] is accompanied by any relevant [F18approved body] or conformity assessment body identification number for that device.

(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a [F16UK marking], meeting the requirements set out in [F17Annex 2 of Regulation 765/2008], appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that [F16UK marking] is accompanied by any relevant [F18approved body] or conformity assessment body identification number for that device.

(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device;

(b)the instructions for use for a relevant device; or

(c)any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the [F16UK marking] or which reduces the visibility or the legibility of the [F16UK marking].

[F19(6) In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

(a)as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

(b)as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).]

CE marking of in vitro diagnostic medical devicesN.I.

36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a CE marking which—

(a)meets the requirements set out in Annex X;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a CE marking which—

(a)meets the requirements set out in Annex X;

(b)is in a visible, legible and indelible form; and

(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device,

if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.

(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex X, appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex X, appears on—

(a)any sales packaging for that device; and

(b)the instructions for use for that device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a)a relevant device;

(b)the instructions for use for a relevant device; or

(c)any sales packaging for a relevant device,

which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.

[F20UK(NI) indication: in vitro diagnostic medical devicesN.I.

36A.—(1) Where the CE marking referred to in regulation 36 is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the device, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before a relevant medical device is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 36.

[F21(3A) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.]

(4) The UK(NI) indication must be affixed by the manufacturer.

(5) Anyone who places a medical device on the market in Northern Ireland must ensure that the manufacturer has complied with their obligations under this regulation.

(6) No person shall supply a relevant device unless the manufacturer has affixed a UK(NI) indication as required by this regulation, if that supply is also a placing on the market or putting into service, or that supply is of a device that has been placed on the market or put into service.]

[F22UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislationE+W+S

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.]

CE marking of in vitro diagnostic medical devices that come within the scope of more than one DirectiveN.I.

37.  Where a relevant device comes within the scope of Directive 98/79 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are satisfied, except where—

(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;

(b)the manufacturer chooses to follow the set of arrangements in Directive 98/79;

(c)the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and

(d)the particulars of Directive 98/79, as published in the Official Journal of the [F65European Union], are given in the documents, notices or instructions accompanying the device.

In vitro diagnostic medical devices not ready for useU.K.

38.  Subject to regulation 39, no person shall—

(a)put into service a relevant device;

(b)supply a relevant device—

(i)if that supply is also a putting into service of that device, or

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

which is not ready for use.

[F23Applications for approval of coronavirus test devicesU.K.

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

(c)a district council in Northern Ireland,

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

Performance requirements for coronavirus test devicesU.K.

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—

“extracted molecular test” means an in vitro diagnostic medical device which—

“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—

“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—

Register of approved coronavirus test devicesU.K.

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;

(c)the country in which the manufacturer is established;

(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 [F24this Part] E+W+S

39.—(1) A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—

(a)the device is not used on any specimen taken from the participants; and

(b)a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of F25... these Regulations.

(2) Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a [F26UK marking], where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

[F27(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.]

Exemptions from regulations 34, 36 and 38N.I.

39.—(1) A relevant device being shown at a trade fair, exhibition, scientific gathering or technical gathering is not being placed on the market or put into service if—

(a)the device is not used on any specimen taken from the participants; and

(b)a visible sign clearly indicates that the device cannot be marketed or put into service until it complies with the requirements of Directive 98/79 or these Regulations.

(2) Regulations 34, 36 and 38 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

[F28Exemptions for coronavirus test devicesU.K.

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 [F29UK marking] to in vitro diagnostic medical devicesE+W+S

40.—(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a [F30UK marking] only if its manufacturer or [F31their UK responsible person]—

(a)fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

(b)declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of [F32this Part] which apply to it; and

(c)ensures that the device meets the provisions of [F32this Part] which apply to it.

(2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a [F30UK marking] only if its manufacturer or [F31their UK responsible person]—

(a)fulfils the applicable obligations imposed by—

(i)Sections 1 to 6 of Annex III,

(ii)Annex IV, or

(iii)Annex V and either Annex VI or Annex VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F32this Part] which apply to it; and

(c)ensures that the device meets the provisions of [F32this Part] which apply to it.

(3) A relevant device referred to in List A in Annex II may bear a [F30UK marking] only if its manufacturer or [F31their UK responsible person]—

(a)fulfils the applicable obligations imposed by—

(i)Annex IV, or

(ii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F32this Part] which apply to it; and

(c)ensures that the device meets the provisions of [F32this Part] which apply to it.

(4) A relevant device referred to in List B in Annex II may bear a [F30UK marking] only if its manufacturer or [F31their UK responsible person]—

(a)fulfils the applicable obligations imposed by—

(i)Annex IV,

(ii)Annexes V and VI, or

(iii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of [F32this Part] which apply to it; and

(c)ensures that the device meets the provisions of [F32this Part] which apply to it.

Procedures for affixing a CE marking to in vitro diagnostic medical devicesN.I.

40.—(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;

(b)declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

(2) A relevant device which is a device for self-testing but which is not referred to in a list in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Sections 1 to 6 of Annex III,

(ii)Annex IV, or

(iii)Annex V and either Annex VI or Annex VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

(3) A relevant device referred to in List A in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex IV, or

(ii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

(4) A relevant device referred to in List B in Annex II may bear a CE marking only if its manufacturer or his authorised representative—

(a)fulfils the applicable obligations imposed by—

(i)Annex IV,

(ii)Annexes V and VI, or

(iii)Annexes V and VII;

(b)declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 98/79 which apply to it; and

(c)ensures that the device meets the provisions of Directive 98/79 which apply to it.

Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devicesE+W+S

41.—(1) A manufacturer of a relevant device or, where applicable, [F33their UK responsible person] who is required to follow, or follows or has followed a conformity assessment procedure set out in [F34this Part] shall observe the manufacturer’s obligations set out in that procedure [F35that apply to the manufacturer or, as the case may be, their UK responsible person].

(2) A manufacturer of a relevant device or, where applicable, [F33their UK responsible person] shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with [F34this Part] at an intermediate stage of manufacture of the device.

(3) A manufacturer or, where applicable, [F33their UK responsible person] shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

(a)the declaration of conformity for that device;

(b)the technical documentation referred to in Annexes III to VIII relating to that device; and

(c)the decisions, reports and certificates of [F36approved bodies] relating to that device,

for a period ending five years after the manufacture of the last product.

(4) A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine M1.

F37(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

41.—(1) A manufacturer of a relevant device or, where applicable, his authorised representative who is required to follow, or follows or has followed a conformity assessment procedure set out in Directive 98/79 shall observe the manufacturer’s obligations set out in that procedure that apply to him.

(2) A manufacturer of a relevant device or, where applicable, his authorised representative shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 98/79 at an intermediate stage of manufacture of the device.

(3) A manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

(a)the declaration of conformity for that device;

(b)the technical documentation referred to in Annexes III to VIII relating to that device; and

(c)the decisions, reports and certificates of notified bodies relating to that device,

for a period ending five years after the manufacture of the last product.

(4) A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine M2.

(5) Until the European databank referred to in article 12 has been established, the manufacturer or, where applicable, his authorised representative shall, in respect of any relevant device which the manufacturer has placed on the market [F66in Northern Ireland], provide the Secretary of State with the data referred to in article 12(1)(a), and that data shall be provided in English.

[F38Approved bodies] and the conformity assessment procedures for in vitro diagnostic medical devicesE+W+S

42.—(1) [F39An approved body] which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)take account of the results of any assessment or verification operations which have been carried out F40... at an intermediate stage of manufacture of the device;

(b)take account of any relevant information relating to the characteristics and performance of that device, F41...; and

(c)lay down, by common accord with the manufacturer or [F42their UK responsible person], the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

(2) Where [F43an approved body] takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

(3) Where [F44an approved body] and a manufacturer or [F45their UK responsible person] have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or [F45their UK responsible person], extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

UK notified bodies and the conformity assessment procedures for in vitro diagnostic medical devicesN.I.

42.—(1) A UK notified body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

(a)take account of the results of any assessment or verification operations which have been carried out in accordance with Directive 98/79 at an intermediate stage of manufacture of the device;

(b)take account of any relevant information relating to the characteristics and performance of that device, including in particular the results of any relevant tests and verification relating to that device already carried out before 7th June 2000; and

(c)lay down, by common accord with the manufacturer or his authorised representative, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

(2) Where a UK notified body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

(3) Where a UK notified body and a manufacturer or his authorised representative have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or his authorised representative, extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

Devices for performance evaluationE+W+S

43.  No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or [F46their UK responsible person]—

(a)has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

(b)ensures that—

(i)the device conforms with the documentation mentioned in the said section 2, and

(ii)the relevant requirements of [F47these Regulations] are complied with as respects that device; and

(c)undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

Devices for performance evaluationN.I.

43.  No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or his authorised representative—

(a)has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

(b)ensures that—

(i)the device conforms with the documentation mentioned in the said section 2, and

(ii)the relevant requirements of the Directive are complied with as respects that device; and

(c)undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

[F48[F49Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluationU.K.

44.—(1) Paragraph (2) applies—

(a)in relation to relevant devices that are Annex II devices or devices for self-testing, to—

(i)a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland, or makes available for performance evaluation, any relevant device;

F50(ii). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

(iv)a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

(b)in relation to relevant devices other than Annex II devices or devices for self-testing, to—

(i)a manufacturer who places a device on the Northern Ireland market, or makes such a device available for performance evaluation, and has a registered place of business in Northern Ireland;

(ii)an authorised representative with a registered place of business in Northern Ireland.

(2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

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

(b)supply the Secretary of State with—

(i)a description of each category of device concerned;

(ii)the relevant information in paragraph (7);

F51(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)in the case of an authorised representative, supply the Secretary of State with—

(i)written evidence that they have been designated as an authorised representative;

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

(iii)where the person placing the devices concerned on the market, or making them available for performance evaluation, is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market, or making them available for performance evaluation;

(e)inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

(3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

(4) The obligations in paragraph (2) begin to apply—

(a)where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1st January 2021;

(b)in circumstances other than those described in sub-paragraph (a)—

(i)in the case of a relevant device that is a List A device, on 1st May 2021;

(ii)in the case of a relevant device that is a device for self-testing, on 1st September 2021; and

(iii)in the case of a relevant device that is a List B device, on 1st September 2021.

F52(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F53(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7) In this regulation “relevant information” means—

(a)in relation to a new relevant device, a statement indicating that the device is a new relevant device;

(b)if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

(c)if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

(d)in relation to devices in a list in Annex II and devices for self-testing—

(i)all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

(ii)if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

(e)in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

(8) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

(9) In paragraphs (7) and (8) a device is a “new relevant device” if—

(a)there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or

(b)use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.]]

[F54[F55Obligations in Part IV which are met by complying with obligations in Directive 98/79U.K.

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 as [F56it had effect on 25 May 2022];

(b)“Regulation 722/2012” 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) [F57Subject to to paragraph (3A),] 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;

[F58(ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 110(2) of Regulation (EU) 2017/746;]

(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)[F59has drawn up before 26 May 2022] an EU Declaration of Conformity in accordance with Article 9;

(g)ensures that the declaration of conformity is prepared in or translated into English.

[F60(3A) Paragraph (3) only applies to a relevant device for which the conformity assessment procedure under Article 9 did not require the involvement of a notified body, if the conformity assessment procedure for that device under Article 48 of Regulation (EU) 2017/746 would require the involvement of a notified body.]

(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”.]]

[F55Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746E+W+S

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 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;

[F61(ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;]

(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”.]