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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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Made: 20th May 2002

Laid before Parliament: 21st May 2002

Coming into force: 13th June 2002

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to medical devices, in exercise of the powers conferred by the said section 2(2), in exercise, with the consent of the Treasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973, in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 1987, and in exercise of all other powers enabling him in that behalf, after consultation in accordance with section 11(5) of the Consumer Protection Act 1987 with organisations appearing to him to be representative of interests substantially affected by these Regulations, with such other persons considered by him appropriate and with the Health and Safety Commission, hereby makes the following Regulations:—

PART I — Introductory Provisions Relating to all Medical Devices

Citation and commencement

1

These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.

Interpretation

2

(1) ... In these Regulations ...—

“active implantable medical device” means a medical device which—relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; andis intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced,even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product;

“approved body” is to be construed in accordance with regulation A45;

“CE marking” means a conformity marking consisting of the initials “CE”;

“clinical data” means the safety or performance information that is generated from the use of a device, derived from—clinical investigations of the device concerned; orclinical investigations or other studies reported in scientific literature of a similar device for which equivalence to the device in question can be demonstrated; orpublished or unpublished reports on other clinical experiences of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

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

“designated standard” has the meaning given in regulation 3A;

“device for performance evaluation” means a product which is intended by its manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises;

“Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices as it had effect immediately before IP completion day;

“Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as it had effect immediately before IP completion day;

“Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices as it had effect immediately before IP completion day;

“Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;

“Directive 2005/50” means Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices;

“Directive 2007/47” means Directive 2007/47/EC of the European Parliament and of the Council amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market;

“... CAB” shall be construed in accordance with regulation 48(1);

“hazard” means a potential source of injury or damage to health;

“hip, knee or shoulder replacement” means an implantable component part of a total joint replacement system which is intended to provide a function similar to that of either a natural hip joint, a natural knee joint or a natural shoulder joint, other than ancillary components (screws, wedges, plates and instruments);

“intended for clinical investigation” means— intended for use by a registered medical practitioner when conducting investigations of that device in an adequate human clinical environment; orintended for use by any other person in Great Britain who, by virtue of their professional qualification, is authorised to carry out investigations of that device in an adequate human clinical environment;

“intended purpose” means—in relation to an active implantable medical device, the use for which it is intended and for which it is suited according to the data supplied by the manufacturer in the instructions relating to it;in relation to any other medical device, the use to which the device is intended according to the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials;

“in vitro diagnostic medical device” means a medical device which—is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; andis intended by the manufacturer to be usedin vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—concerning a physiological or pathological state,concerning a congenital abnormality,to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, orto monitor therapeutic measures,and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used forin vitro diagnostic examination;

“machinery” has the meaning given to it by regulation 4 of the Supply of Machinery (Safety) Regulations 2008;

“manufacturer” means—the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; orany other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient;

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which—is intended by the manufacturer to be used for human beings for the purpose of-diagnosis, prevention, monitoring, treatment or alleviation of disease,diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,investigation, replacement or modification of the anatomy or of a physiological process, orcontrol of conception; anddoes not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means,and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;

“the Medical Devices Directives” means Directive 90/385, Directive 93/42, both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012 and Directive 98/79;

“medicinal product” has the meaning given in regulation 2(1) of the Human Medicines Regulations 2012;

“mutual recognition agreement” means an agreement that—is between the United Kingdom and a country listed in Schedule 2, andcovers matters including the conditions under which the United Kingdom and that country will accept or recognise the results of conformity assessment procedures undertaken by the each other's designated bodies;

“placing on the market” means, in relation to a medical device, the first making available in return for payment or free of charge of a new or fully refurbished device, other than a device intended for clinical investigation, with a view to distribution, use, or both, on the Great Britain market and related expressions must be construed accordingly;

“putting into service” means—in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;in relation to any other medical device, the first making available of the device in Great Britain to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

“Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;(as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act)

“Regulation (EU) No 722/2012”— in Part 4A, has the meaning given in regulation 44ZC;in all other Parts 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 retained under section 3 of the European Union (Withdrawal) Act 2018 and modified under section 8 of that Act);

“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;

“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;

“Regulation (EU) 2022/1107” means Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council;

“relevant essential requirements”—in Part 4A, has the meaning given in regulation 44ZC;in all other Parts, in relation to a medical device, means the essential requirements set out in Annex 1 of Directive 90/385, Annex I of Directive 93/42 or Annex I of Directive 98/79 which apply to it, but not including, in the case of a device intended for clinical investigation, such of those requirements, or aspects of them, as are the subject of the investigation;

“specimen receptacle” means a medical device which (whether vacuum-type or not) is specifically intended by its manufacturer to be used for the primary containment and preservation of specimens derived from the human body for the purpose ofin vitro diagnostic examination;

“stable derivatives device” means a medical device that contains human blood, blood products, plasma or blood cells of human origin, and which incorporates, as an integral part, a substance which—if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of regulation 2(2) of the Human Medicines Regulations 2012; andis liable to act upon the human body with action ancillary to that of the device;

“statistical review” means a review of the statistical sections of the written notice which a manufacturer or their UK responsible person submits to the Secretary of State pursuant to regulation 16(1) or 29(1) in respect of an intended clinical investigation of a relevant device;

“supply”, in relation to a medical device, means—the supply of, or the offer or agreement to supply, the device; orthe exposure or possession for supply of the device;

“third country conformity assessment body” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations;

“UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008;

“UK responsible person” means a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations; and

“working day” means any day which is not Saturday, Sunday, Christmas Day, Good Friday or a day which is a bank holiday in any part of Great Britain under the Banking and Financial Dealings Act 1971.

(1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.

(1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.

(2) In these Regulations, unless the context otherwise requires, a reference—

(a) to a numbered regulation, Part or Schedule is to the regulation or Part of, or the Schedule to, these Regulations bearing that number;

(b) in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and

(c) in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.

Scope of these Regulations

3

These Regulations shall not apply to—

(a) medicinal products governed by the Human Medicines Regulations 2012 (including medicinal products derived from human blood or human plasma ...);

(b) human blood, human blood products, plasma or blood cells of human origin;

(c) devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for —

(i) stable derivatives devices,

(ii) active implantable medical devices and accessories to such devices, and

(iii) in vitro diagnostic medical devices and accessories to such devices,;

(d) transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin , except for ..., in vitro diagnostic medical devices and accessories to such devices save where medicinal products are incorporated as ancillary to the device;

(e) transplants or tissues or cells of animal origin, unless—

(i) a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or

(ii) a product is ... an in vitro diagnostic medical device, or an accessory to such a device;

(f) cosmetic products governed by Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products; or

(g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transitional provisions

4

(1) Part II shall not be applied before 1st July 2004 in respect of a device which has been subjected to EEC pattern approval before 1st January 1995 in accordance with the Clinical Thermometers (EEC Requirements) Regulations 1993 .

(2) Part II shall not be applied—

(a) before 10th January 2007 in respect of a stable derivatives device placed on the market without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002; or

(b) before 10th January 2009 in respect of a stable derivatives device put into service without a CE marking, if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 10th January 2002.

(3) Part IV shall not be applied before 7th December 2003 in respect of a device placed on the market which is—

(a) anin vitro diagnostic medical device without a CE marking; or

(b) a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is placed on the market as in force on 7th December 1998.

(4) Part IV shall not be applied before 7th December 2005 in respect of a device put into service which is—

(a) anin vitro diagnostic medical device without a CE marking; or

(b) a device for performance evaluation and the manufacturer or his authorised representative does not indicate, directly or indirectly, that it is a device which is subject to the provisions of these Regulations,

if the device satisfies the requirements of the laws of that part of the United Kingdom in which it is put into service as in force on 7th December 1998.

(5) Regulation 13(4) shall not be applied before 1st March 2004 in respect of breast implants which—

(a) bore a CE marking before 1st September 2003; and

(b) satisfy the requirements in respect of relevant devices falling within Class IIb set out in regulation 13(3).

(6) Regulation 19A shall not be applied before 1st October 2004 in respect of a device placed on the market before 1st April 2004.

PART II — General Medical Devices

Interpretation of Part II

5

(1) In this Part ...—

“accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;

“custom-made device” means a relevant device that is—manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; andintended for the sole use of a particular patient,but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;

“relevant device” shall be construed in accordance with regulation 6;

“single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and

“system or procedure pack” has the same meaning as in article 12 of Directive 93/42.

(2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.

Scope of Part II

6

The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—

(a) active implantable medical devices and accessories to such devices; and

(b) in vitro diagnostic medical devices and accessories to such devices; and

(c) devices that come within the scope of Directive 93/42 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.

Classification of general medical devices

7

(1) For the purposes of this Part and Part VI, devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50.

(2) In the event of a dispute between a manufacturer and an approved body over the classification of a device, the matter shall be referred to the Secretary of State, who shall determine the classification of the device in accordance with the classification criteria set out in Annex IX of Directive 93/42 , read with Directive 2003/12 and Directive 2005/50.

Essential requirements for general medical devices

8

(1) Subject to regulation 12, 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 and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

(2) Subject to regulation 12, 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 and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

(3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.

Determining compliance of general medical devices with relevant essential requirements

9

(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) Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.

(3) In the case of a relevant device which is being or has been put into service—

(a) the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and

(b) the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if—

(i) such instructions are in English ...

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

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard, unless there are reasonable grounds for suspecting that it does not comply with that requirement.

(5) A custom-made device—

(a) in respect of which the conditions specified in Annex VIII are satisfied; and

(b) in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII,

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

(a) ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

(b) ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.

(6) Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or their UK responsible person, has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device.

(7) A device intended for clinical investigation in respect of which—

(a) the conditions specified in Annex VIII are satisfied;

(b) notice has been given under regulation 16(1); and

(i) no notice has been given under regulation 16(4) within the period of 60 days there referred to, or

(ii) notice has been given under regulation 16(5),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(8) A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I ... that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it.

(9) Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC and Directive 93/42, the relevant basic health and safety requirements of Regulation (EU) 2016/425 shall also be fulfilled.

CE marking of general medical devices

10

(1) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a UK marking which—

(a) meets the requirements set out in Annex 2 of Regulation (EC) No 765/2008;

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

(2) Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a UK marking which—

(a) meets the requirements set out in Annex 2 of Regulation (EC) No 765/2008;

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

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 regulations 12 and 14, no person shall place on the market or put into service a relevant device unless a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—

(a) any sales packaging for that device; and

(b) the instructions for use for the device,

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

(4) Subject to regulations 12 and 14, 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 UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—

(a) any sales packaging for that device; and

(b) the instructions for use for the device,

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

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a) a relevant device or its sterile pack;

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

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

(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 general medical devices that come within the scope of more than one Directive

11

Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.

Exemptions from regulations 8 and 10

12

(1) A relevant device or a single use combination product being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.

(2) Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulation 10 shall not apply to a relevant device which is a system or procedure pack, unless—

(a) the system or procedure pack incorporates a medical device which does not bear a UK marking; or

(b) the chosen combination of medical devices is not compatible in view of their original intended use.

(4) Regulation 10 shall not apply to single-use combination products, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device which forms part of that product.

(5) Regulations 8 and 10 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 UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

(6) Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a UK marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.

(7) In paragraph (6), the Secretary of State, in determining whether another standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Procedures for affixing a CE marking to general medical devices

13

(1) A relevant device falling within Class I may bear a UK marking only if its manufacturer or their UK responsible person—

(a) fulfils the applicable obligations imposed by Annex VII;

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

(2) A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person—

(a) fulfils the applicable obligations imposed by—

(i) Annex II, excluding Section 4 of that Annex, or

(ii) Annex VII, together with Annex IV, V or VI;

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

(3) A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person—

(a) fulfils the applicable obligations imposed by—

(i) Annex II, excluding Section 4 of that Annex, or

(ii) Annex III, together with Annex IV, V or VI;

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

(4) A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person—

(a) fulfils the applicable obligations imposed by—

(i) Annex II, or

(ii) Annex III, together with Annex IV or V;

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

(d) fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

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

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

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

14

(1) Subject to paragraph (3), no person shall supply a system or procedure pack (if that supply is also a placing on the market, or if that supply is of a system or procedure pack that has been placed on the market) unless—

(a) the medical devices in that system or procedure pack are for use within their intended purpose and within the limits of use specified by their manufacturer;

(b) the person who places or has placed it on the market has drawn up a declaration that—

(i) he has verified the mutual compatibility of the medical devices in that system or procedure pack in accordance with the manufacturers’ instructions, and he has carried out his operations in accordance with these instructions,

(ii) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers, and

(iii) his production of the system or procedure pack is subjected to appropriate methods of internal control and inspection,

and that declaration is true at the time it is made and continues to be true.

(2) Subject to paragraph (3), no person shall supply—

(a) a system or procedure pack which was sterilised before being placed on the market; or

(b) a relevant device (including a system or procedure pack) which is designed by its manufacturer to be sterilised before use,

(if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless the person who places, or who has placed, the device on the market satisfies the conditions set out in paragraph (4).

(3) Paragraphs (1) and (2)(a) shall only apply to a system or procedure pack if, by virtue of regulation 12(3), regulation 10 does not apply to that system or procedure pack.

(4) The conditions referred to in paragraph (2) are that the person shall—

(a) follow the procedures referred to in either Annex II or IV that relate to obtaining sterility; and

(b) if the device has been sterilised, make a written declaration that sterilisation has been carried out in accordance with the manufacturer’s instructions.

(4A) The application of Annex II or IV and the intervention of the approved body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.

(5) Where a conformity assessment procedure is carried out in respect of a relevant device (including a device which is a system or procedure pack) pursuant to this regulation—

(a) no person shall affix a UK marking to that device as a result of that procedure; and

(b) no person shall supply that device (if that supply is also a placing on the market, or if that supply is of a device that has been placed on the market) unless it is accompanied by the information referred to in Section 13 of Annex I, which shall include, where appropriate, the information supplied by the manufacturers of the devices which have been put together.

(6) The declarations referred to in paragraph (1)(b) and (4)(b) shall be kept available for the Secretary of State by the person responsible for placing the product on the market for a period of five years.

Procedures for custom-made general medical devices

15

No person shall supply a custom-made device (if that supply is also a placing on the market, or if that supply is of a custom-made device that has been placed on the market) unless its manufacturer or their UK responsible person—

(a) has drawn up a statement containing the information required by Sections 1, 2 and 2.1 of Annex VIII , read with Regulation (EU) No 722/2012;

(b) has undertaken to keep available for the Secretary of State 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 Directive 93/42; and

(c) takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex VIII; ...

(d) keeps available for the Secretary of State, for a minimum period of five years, the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b) ; and

(e) ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.

Procedures for general medical devices for clinical investigations

16

(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in Great Britain unless, before he does so, the manufacturer of the device or their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a) subject to paragraph (3), the statement required by Sections 1 and 2.2 of Annex VIII , read with Regulation (EU) No 722/2012; and

(b) an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.2 of Annex VIII for a minimum period of five years.

(1A) A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

(a) obtain advice on regulatory requirements relating to an intended clinical investigation; or

(b) obtain a statistical review in relation to an intended clinical investigation.

(2) Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a UK marking otherwise than in breach of regulation 13, unless the aim of the intended investigation is to determine whether the device may be used for a purpose other than that in respect of which it was UK marked in accordance with regulation 13.

(3) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex VIII need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or their UK responsible person as soon as it becomes available.

(4) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(5) The Secretary of State may, in respect of notice in writing given by a manufacturer or their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or their UK responsible person—

(a) that the relevant device may be made available for the purposes of the intended investigation; or

(b) if the ethics committee opinion required under Section 2.2 of Annex VIII is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(6) A written notice pursuant to paragraph (5) may—

(a) where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b) at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(7) Where a written notice pursuant to paragraph (5) in respect of a relevant device has been withdrawn by the Secretary of State—

(a) further clinical use of the relevant device in the investigation is prohibited; and

(b) no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(8) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or their UK responsible person, shall—

(a) take all necessary measures to ensure that the manufacturing process for the relevant device produces devices manufactured in accordance with the documentation referred to in the first paragraph of Section 3.2 of Annex VIII;

(b) authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation; and

(c) keep the information contained in the statement and the undertaking referred to in paragraph (1) for a minimum period of five years.

(9) The grounds of public health or public policy referred to in paragraph (4) or (6)(b) are met, amongst other reasons, if—

(a) the manufacturer or their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (8); or

(b) the manufacturer or their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1)(b).

(10) No person shall conduct a clinical investigation of a relevant device—

(a) otherwise than in accordance with Annex X; and

(b) otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (6)(a),

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or their UK responsible person shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex X.

(11) The manufacturer, or their single UK responsible person, shall—

(a) notify the Secretary of State of the end of the clinical investigation; and

(b) provide justification where premature termination has resulted.

Manufacturers etc. and conformity assessment procedures for general medical devices

17

(1) A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in this Part 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, their 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 this Part at an intermediate stage of manufacture of the device.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

UK notified bodies and the conformity assessment procedures for general medical devices

18

(1) An 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 ... 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, ...; 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 Annex II to IV.

(2) Where an approved body takes a decision in accordance with Annex II, III, V or VI, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3) Where an approved body and a manufacturer or the manufacturer’s 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 the manufacturer’s UK responsible person, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Registration of persons placing general medical devices on the market

19

(1) Paragraph (2) applies—

(a) in relation to relevant devices that are neither Class I devices nor custom-made devices, to—

(i) a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland any general medical device of any class, other than a system or procedure pack which is not CE marked;

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

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

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

(b) in relation to Class I devices that are not custom-made devices, to—

(i) a manufacturer who places a device on the Northern Ireland market and has a registered place of business in Northern Ireland;

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

(c) to a person with a registered place of business in Northern Ireland who sterilises before use any devices designed by their manufacturer to be sterilised before use.

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

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

(b) supply the Secretary of State with a description of each category of device concerned;

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

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

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

(iii) where the person placing the devices concerned on the market is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market;

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

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

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

(a) in the case of a device that is a Class I device and custom-made devices, on 1st January 2021;

(b) in the case of a device that is a Class III or IIb implantable device, on 1st May 2021;

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

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

PART III — Active Implantable Medical Devices

Interpretation of Part III

20

(1) In this Part...—

“custom-made device” means an active implantable medical device that is—manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; andintended to be used only for a particular patient; and

“relevant device” shall be construed in accordance with regulation 21.

(2) In this Part..., a reference to a numbered ... Annex is to the ... Annex of Directive 90/385 bearing that number.

Scope of Part III

21

(1) The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, ...

(2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.

(3) Where an active implantable device is intended to administer a medicinal product, that device must be governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012.

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Essential requirements for active implantable medical devices

22

(1) Subject to regulation 26, 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 1 which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

(2) Subject to regulation 26, 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 also been placed on the market or put into service,

unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation (EU) No 722/2012 (if applicable).

Determining compliance of active implantable medical devices with relevant essential requirements

23

(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) Any—

(a) determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

(b) evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

(3) In the case of a relevant device which is being or has been put into service—

(a) the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

(b) the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

(i) the instructions are in English ...

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

(4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

(5) A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

(6) A device intended for clinical investigation in respect of which—

(a) the conditions specified in Annex 7 are satisfied;

(b) notice has been given under regulation 29(1); and

(i) no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

(ii) notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

CE marking of active implantable medical devices

24

(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device or its sterile pack bears a UK marking which—

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

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

(2) Subject to regulation 26, no person shall supply a relevant device unless that device or its sterile pack bears a UK marking which—

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

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

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 26, no person shall place on the market or put into service a relevant device unless a UK marking, meeting the requirements set out in Annex 2 of Regulation 765/2008, appears on—

(a) where appropriate, any sales packaging for that device; and

(b) the instructions for use for the device,

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

(4) Subject to regulation 26, 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 UK marking, meeting the requirements set out in Annex 2 of Regulation 765/2008, appears on—

(a) where appropriate, any sales packaging for that device; and

(b) the instructions for use for the device,

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

(5) No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

(a) a relevant device or its sterile pack;

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

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

(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 active implantable medical devices that come within the scope of more than one Directive

25

Exemptions from regulations 22 and 24

26

(1) A relevant device being shown at a trade fair, exhibition, demonstration or similar gathering is not being placed on the market or put into service if a visible sign clearly indicates that the device or product cannot be marketed or put into service until it complies with the requirements of ... these Regulations.

(2) Regulation 24 shall not apply to a custom-made device or a device intended for clinical investigation.

(3) Regulations 22 and 24 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 UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

(4) Regulations 22 and 24 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a UK marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 22 and 24, may be placed on the market.

(5) In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.

Procedures for affixing a CE marking to active implantable medical devices

27

A relevant device may bear a UK marking only if its manufacturer or their UK responsible person—

(a) fulfils the applicable obligations imposed by—

(i) Annex 2, or

(ii) Annex 3, together with Annex 4 or 5;

(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part that apply to it; ...

(d) fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

Procedures for custom-made active implantable medical devices

28

(a) has drawn up the statement containing the information required by Section 2.1 of Annex 6, read with Regulation (EU) No 722/2012;

(b) has undertaken to keep available for the Secretary of State the documentation referred to in Section 3.1 of Annex 6;

(c) takes all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1 of Annex 6; and

(d) keeps available for the Secretary of State the information contained in the statement referred to in paragraph (a) and in the undertaking referred to in paragraph (b).

Procedures for active implantable medical devices for clinical investigations

29

(1) No person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in Great Britain unless, before he does so, the manufacturer of the device or their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of—

(a) subject to paragraph (2), the statement required by Section 2.2 of Annex 6 , read with Regulation (EU) No 722/2012; and

(b) an undertaking to keep available for the Secretary of State the documentation referred to in Section 3.1 and 3.2 of Annex 6.

(1A) A manufacturer or their UK responsible person may request a meeting with the Secretary of State in advance of giving notice in writing to the Secretary of State pursuant to paragraph (1) in order to—

(a) obtain advice on regulatory requirements relating to an intended clinical investigation; or

(b) obtain a statistical review in relation to an intended clinical investigation.

(2) The ethics committee opinion that forms part of the information required under Section 2.2 of Annex 6 need not be provided to the Secretary of State at least 60 days prior to the intended investigation, but if it is not provided at least 60 days prior to the intended investigation, it must be provided to the Secretary of State by the manufacturer or their UK responsible person as soon as it becomes available.

(3) If, within 60 days of the formal acceptance by the Secretary of State of the notice in writing given pursuant to paragraph (1), the Secretary of State gives written notice to the manufacturer or UK responsible person (whichever gave the notice pursuant to paragraph (1)) that, on grounds of public health or public policy, the relevant device should not be made available for the purposes of the intended investigation, no person shall supply the relevant device (if that supply is also a making available of the device) for those purposes.

(4) The Secretary of State may, in respect of notice in writing given by a manufacturer or their UK responsible person pursuant to paragraph (1), give written notice to the manufacturer or their UK responsible person—

(a) if the ethics committee opinion required under Section 2.2 of Annex 6 is favourable, that the relevant device may be made available for the purposes of the intended investigation; or

(b) if the ethics committee opinion required under Section 2.2 of Annex 6 is not available, that the relevant device may be made available for the purposes of the intended investigation once a favourable opinion in respect of the investigational plan for the intended investigation has been delivered by the committee.

(5) A written notice pursuant to paragraph (4) may—

(a) where appropriate be given subject to conditions imposed by the Secretary of State, which are to be included in the notice;

(b) at any time be withdrawn on grounds of public health or public policy by the Secretary of State.

(6) Where a written notice pursuant to paragraph (4) in respect of a relevant device has been withdrawn by the Secretary of State—

(a) further clinical use of the relevant device in the investigation is prohibited; and

(b) no person shall supply that relevant device for the purposes of the investigation (if that supply is also a making available of the device),

unless the Secretary of State issues a further written notice pursuant to that paragraph stating that the relevant device may again be made available for the purposes of the investigation.

(7) The manufacturer of a relevant device intended for clinical investigation to which paragraph (1) applies, or their UK responsible person, shall—

(a) take all necessary measures to ensure that the manufacturing process ensures that each device manufactured according to that process conforms to the documentation referred to in the first paragraph of Section 3.1, and the first paragraph of Section 3.2, of Annex 6;

(b) keep available for the Secretary of State the information contained in the statement and the undertaking referred to in paragraph (1); and

(c) authorise the assessment, including audit where necessary, of the effectiveness of the measures which he takes pursuant to this regulation.

(8) The grounds of public health or public policy referred to in paragraphs (3) and (5)(b) are met, amongst other reasons, if—

(a) the manufacturer or their UK responsible person does not authorise an assessment by the Secretary of State, whether by means of an audit, an inspection or otherwise, of the effectiveness of the measures referred to in paragraph (7); or

(b) the manufacturer or their UK responsible person does not make available to the Secretary of State documentation which he has undertaken to keep available in accordance with paragraph (1).

(9) No person shall conduct a clinical investigation of a relevant device—

(a) otherwise than in accordance with Annex 7; and

(b) otherwise than in accordance with any conditions imposed by the Secretary of State pursuant to paragraph (5)(a),

(10) The manufacturer, or their single UK responsible person, shall—

(a) notify the Secretary of State of the end of the clinical investigation; and

(b) provide justification where premature termination has resulted.

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

30

(1) A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure in the Annexes referred to in regulation 27(a) 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, their UK responsible person shall, when following a conformity assessment procedure in the Annexes referred to in regulation 27(a), take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device.

(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

UK notified bodies and the conformity assessment procedures for active implantable medical devices

31

(1) An 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 in accordance with this Part at an intermediate stage of manufacture of the device; and

(b) lay down, by common accord with the manufacturer or their UK responsible person, the time limits for completion of the assessment and verification operations referred to in Annex 2 or 3.

(2) Where an approved body takes a decision in accordance with Annex 2, 3 or 5, they shall specify the period of validity of the decision, which initially shall be for a period of not more than five years.

(3) Where an approved body and a manufacturer or the manufacturer’s 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 the manufacturer’s UK responsible person, extend the period of validity of the decision for further periods of up to five years, each such period commencing on the expiry of the previous period.

PART IV — In Vitro Diagnostic Medical Devices

Interpretation of Part IV

32

(1) In this Part ...—

“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—itself an in vitro diagnostic medical device;an invasive sampling medical device; ora 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 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 ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Scope of Part IV

33

(1) The requirements of this Part in respect of relevant devices apply in respect ofin vitro diagnostic medical devices (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; and

(b) devices 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; and

(b) devices 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.

Essential requirements for in vitro diagnostic medical devices

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.

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

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 ... .

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

CE marking of in vitro diagnostic medical devices

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 UK marking which—

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

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

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

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

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

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 UK marking, meeting the requirements set out in Annex 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 UK marking is accompanied by any relevant approved 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 UK marking, meeting the requirements set out in Annex 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 UK marking is accompanied by any relevant approved 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

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

(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 devices that come within the scope of more than one Directive

37

In vitro diagnostic medical devices not ready for use

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.

Exemptions from regulations 34, 36 and 38

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 ... 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 UK marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

(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.

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

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 UK marking only if its manufacturer or their 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 this Part which apply to it; and

(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 UK marking only if its manufacturer or their 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 this Part which apply to it; and

(3) A relevant device referred to in List A in Annex II may bear a UK marking only if its manufacturer or their 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 this Part which apply to it; and

(4) A relevant device referred to in List B in Annex II may bear a UK marking only if its manufacturer or their 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 this Part which apply to it; and

Manufacturers etc. and conformity assessment procedures forin vitro diagnostic medical devices

41

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

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