Statutory Instrument 2002 No. 618

      The Medical Devices Regulations 2002

      © Crown Copyright 2002

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STATUTORY INSTRUMENTS

2002 No. 618

CONSUMER PROTECTION

The Medical Devices Regulations 2002

  Made 20th May 2002 
  Laid before Parliament 21st May 2002 
  Coming into force 13th June 2002 


ARRANGEMENT OF REGULATIONS


PART I

Introductory Provisions Relating to all Medical Devices
1. Citation and commencement
2. Interpretation
3. Scope of these Regulations
4. Transitional provisions

PART II

General Medical Devices
5. Interpretation of Part II
6. Scope of Part II
7. Classification of general medical devices
8. Essential requirements for general medical devices
9. Determining compliance of general medical devices with relevant essential requirements
10. CE marking of general medical devices
11. CE marking of general medical devices that come within the scope of more than one Directive
12. Exemptions from regulations 8 and 10
13. Procedures for affixing a CE marking to general medical devices
14. Procedures for systems and procedure packs, and for devices to be sterilised before use
15. Procedures for custom-made general medical devices
16. Procedures for general medical devices for clinical investigations
17. Manufacturers etc. and conformity assessment procedures for general medical devices
18. UK notified bodies and the conformity assessment procedures for general medical devices
19. Registration of persons placing general medical devices on the market

PART III

Active Implantable Medical Devices
20. Interpretation of Part III
21. Scope of Part III
22. Essential requirements for active implantable medical devices
23. Determining compliance of active implantable medical devices with relevant essential requirements
24. CE marking of active implantable medical devices
25. CE marking of active implantable medical devices that come within the scope of more than one Directive
26. Exemptions from regulations 22 and 24
27. Procedures for affixing a CE marking to active implantable medical devices
28. Procedures for custom-made active implantable medical devices
29. Procedures for active implantable medical devices for clinical investigations
30. Manufacturers etc. and conformity assessment procedures for active implantable medical devices
31. UK notified bodies and the conformity assessment procedures for active implantable medical devices

PART IV

in vitro Diagnostic Medical Devices
32. Interpretation of Part IV
33. Scope of Part IV
34. Essential requirements for in vitro diagnostic medical devices
35. Determining compliance of in vitro diagnostic medical devices with relevant essential requirements
36. CE marking of in vitro diagnostic medical devices
37. CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive
38. In vitro diagnostic medical devices not ready for use
39. Exemptions from regulations 34, 36 and 38
40. Procedures for affixing a CE marking to in vitro diagnostic medical devices
41. Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
42. UK notified bodies and conformity assessment procedures for in vitro diagnostic medical devices
43. Devices for performance evaluation
44. Registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation

PART V

Notified Bodies, Conformity Assessment Bodies and Marking of Products
45. Designation etc. of UK notified bodies
46. Choice of notified bodies and conformity assessment bodies
47. General matters relating to notified bodies
48. Designation etc. of EC conformity assessment bodies
49. Fees charged by UK notified bodies and EC conformity assessment bodies
50. Products incorrectly marked with a notified body or conformity assessment body number
51. Products incorrectly marked with a CE marking

PART VI

Fees Charged by the Secretary of State
52. Interpretation of Part VI
53. Fees payable in connection with registration of devices and changes to registration details
54. Fees payable in connection with the designation etc. of UK notified bodies
55. Fees payable in connection with the designation etc. of EC conformity assessment bodies
56. Fees payable in connection with clinical investigation notices
57. Unpaid fees
58. Waivers, reductions and refunds

PART VII

General, Enforcement and Miscellaneous
59. Interpretation of Part VII
60. Designation etc. of authorised representatives
61. Enforcement etc.
62. Compliance notices
63. Restriction notices
64. Notification of Decisions etc.
65. Centralised systems of records
66. Revocations

SCHEDULES

  1. Association Agreements

  2. Mutual Recognition Agreements

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972[1] in relation to measures relating to medical devices[2], 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[3], in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 1987[4], 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, unless the context otherwise requires - 

    "the 1987 Act" means the Consumer Protection Act 1987;

    "active implantable medical device" means a medical device which - 

    (a) 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; and

    (b) is 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;

    "Association Agreement" means an Agreement, listed in Schedule 1, establishing an Association between the European Communities and their Member States, on the one part, and another State on the other part (referred to in these Regulations as a "State which is a Party to an Association Agreement") on Conformity Assessment and Acceptance of Industrial Products;

    "authorised representative" means a person established within the Community or in a State which is a Party to an Association Agreement who, explicitly designated by the manufacturer, acts for the manufacturer and may be addressed by authorities and bodies in the Community instead of the manufacturer;

    "CE marking" means a conformity marking consisting of the initials "CE";

    "the Community" means - 

    (a) in the context of any requirement relating to an in vitro diagnostic medical device, the European Community;

    (b) in the context of any requirement relating to any other medical device, the European Economic Area;

    "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 93/42" means Council Directive 93/42/EEC of 14th June 1993 concerning medical devices[7], as amended[8];

    "Directive 98/79" means Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices[9];

    "Directive 2001/83" means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use[10];

    "EC CAB" shall be construed in accordance with regulation 48(1);

    "EEA State" means a State which is a Contracting Party to the EEA Agreement;

    "European Economic Area" means the European Economic Area created by the Agreement on the European Economic Area signed at Oporto on 2nd May 1992[11], as adjusted by the Protocol signed at Brussels on 17th March 1993[12] ("the EEA Agreement");

    "harmonised standard" means - 

    (a) a technical specification adopted, on a mandate from the European Commission, by the European Committee for Standardisation or the European Committee for Electrotechnical Standardisation, or by both of those bodies, in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations[13], pursuant to the general guidelines on co-operation between the Commission and the said Committees signed on 13th November 1984; or

    (b) a monograph of the European Pharmacopoeia (in particular any monograph on surgical sutures and the interaction between medicinal products and materials used in medical devices containing medicinal products),

the reference number of which has been published in the Official Journal of the European Communities;

    "intended for clinical investigation" means - 

    (a) in relation to an active implantable medical device, that it is intended for use by a medical specialist when conducting clinical investigations of that device;

    (b) in relation to any other medical device, that it is intended for use by a duly qualified medical practitioner or a professional user when conducting investigations of that device in an adequate human clinical environment;

    "intended purpose" means - 

    (a) 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;

    (b) 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 - 

    (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

    (b) is intended by the manufacturer to be used in 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 - 

      (i) concerning a physiological or pathological state,

      (ii) concerning a congenital abnormality,

      (iii) to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

      (iv) to 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 for in vitro diagnostic examination;

    "manufacturer" means - 

    (a) 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; or

    (b) any 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 an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which - 

    (a) is intended by the manufacturer to be used for human beings for the purpose of-

      (i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

      (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

      (iii) investigation, replacement or modification of the anatomy or of a physiological process, or

      (iv) control of conception; and

    (b) does 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 and Directive 98/79;

    "medical specialist" means a registered medical practitioner who has a qualification as, or is undergoing training intended to lead to qualification as, a specialist;

    "medicinal product" has the meaning given in article 1.2 of Directive 2001/83;

    "Mutual Recognition Agreements" means the agreements, listed in Schedule 2, concluded between the European Community and States which are not part of the European Community on matters including the conditions under which each Party will accept or recognise the results of the conformity assessment procedures undertaken by the other Party's designated bodies;

    "national standard" means a technical specification adopted by a Member State of the Community which transposes, and corresponds to, a harmonised standard;

    "notified body" means a body authorised in accordance with Part V of the Medical Devices Directives to carry out tasks of a notified body or the importing Party under the Medical Devices Directives or the Mutual Recognition Agreements in respect of a conformity assessment procedure;

    "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 Community market;

    "putting into service" means - 

    (a) in relation to an active implantable medical device, the making available of the device to a registered medical practitioner for implantation;

    (b) in relation to any other medical device, the first making available of the device in the Community to a final user, including where a device is used in a professional context for the purposes of medical analysis without being marketed;

    "relevant essential requirements", 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 of in 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 - 

    (a) 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 article 1.10 of Directive 2001/83; and

    (b) is liable to act upon the human body with action ancillary to that of the device;

    "supply", in relation to a medical device, means - 

    (a) the supply of, or the offer or agreement to supply, the device; or

    (b) the exposure or possession for supply of the device;

    "third country conformity assessment body" means a body in a State which is not part of the European Community that is designated in accordance with the Mutual Recognition Agreements to carry out tasks of a notified body under the conformity assessment procedures set out in the Medical Devices Directives; and

    "UK notified body" shall be construed in accordance with regulation 45.

    (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 - 

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[18].

    (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) an in 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) an in 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.



PART II

General Medical Devices

Interpretation of Part II
     5.  - (1) In this Part, unless the context otherwise requires - 

    "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 - 

    (a) manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user which gives, under his responsibility, specific characteristics as to its design; and

    (b) intended 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, unless the context otherwise requires, 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 - 

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.

    (2) In the event of a dispute between a manufacturer and a notified 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.

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.

    (2) Subject to regulation 12, no person shall supply a relevant device - 

unless that device meets those essential requirements set out in Annex I which apply to it.

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 - 

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

    (5) A custom-made device - 

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) Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or his authorised representative, 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 - 

    (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 of Directive 93/42 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.

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 CE marking which - 

    (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 CE marking which - 

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 CE marking, meeting the requirements set out in Annex XII, appears on - 

and that CE marking is accompanied by any relevant notified 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 CE marking, meeting the requirements set out in Annex XII, appears on - 

and that CE marking is accompanied by any relevant notified 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 - 

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.

CE marking of general medical devices that come within the scope of more than one Directive
     11. Where a relevant device comes within the scope of Directive 93/42 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 also satisfied, except where - 

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 Directive 93/42 or 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 - 

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

Procedures for affixing a CE marking to general medical devices
     13.  - (1) A relevant device falling within Class I may bear a CE marking only if its manufacturer or his authorised representative - 

    (2) A relevant device falling within Class IIa may bear a CE marking only if its manufacturer or his authorised representative - 

    (3) A relevant device falling within Class IIb may bear a CE marking only if its manufacturer or his authorised representative - 

    (4) A relevant device falling within Class III may bear a CE marking only if its manufacturer or his authorised representative - 

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 - 

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

(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 - 

    (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 - 

    (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 his authorised representative - 

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 the United Kingdom unless, before he does so, the manufacturer of the device or his authorised representative has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of - 

    (2) Paragraph (1) shall not apply in respect of an intended clinical investigation of a relevant device that bears a CE 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 CE 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 his authorised representative 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 authorised representative (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 his authorised representative pursuant to paragraph (1), give written notice to the manufacturer or his authorised representative - 

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

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

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 his authorised representative, shall - 

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

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

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

Manufacturers etc. and conformity assessment procedures for general medical devices
     17.  - (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 93/42 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 93/42 at an intermediate stage of manufacture of the device.

    (3) Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep available the technical documentation referred to in - 

UK notified bodies and the conformity assessment procedures for general medical devices
     18.  - (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 - 

    (2) Where a UK notified body takes a decision in accordance with Annex II or III, 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 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 five years, each such period commencing on the expiry of the previous period.

Registration of persons placing general medical devices on the market
     19.  - (1) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person to whom this paragraph applies shall - 

    (2) Paragraph (1) applies to - 

    (3) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a device mentioned in paragraph (2) on the market in the United Kingdom on behalf of a manufacturer who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement shall inform the Secretary of State of - 

    (4) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a system or procedure pack which is not CE marked on the market in the United Kingdom, or who sterilises systems or procedure packs before they are placed on the market, shall - 

    (5) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a relevant device which is a Class IIb or III device on the market in the United Kingdom (including the authorised representative of a manufacturer of a Class IIb or III device who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement) shall, if the Secretary of State so requests, supply the Secretary of State with all data allowing for the identification of the device together with the label and the instructions for use for when the device is put into service within the United Kingdom.

    (6) Registration under this regulation is not required if - 



PART III

Active Implantable Medical Devices

Interpretation of Part III
     20.  - (1) In this Part, unless the context otherwise requires - 

    "custom-made device" means an active implantable medical device that is - 

    (a) manufactured specifically in accordance with a medical specialist's written prescription which gives, under his responsibility, specific characteristics as to its design; and

    (b) intended to be used only for a particular patient; and

    "relevant device" shall be construed in accordance with regulation 21.

    (2) In this Part, unless the context otherwise requires, a reference to a numbered article or Annex is to the article or Annex of Directive 90/385 bearing that number.

Scope of Part III
     21. The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, except for devices that come within the scope of Directive 90/385 and another Directive ("the other Directive") issued by one or more of the institutions of the Community, and

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.

    (2) Subject to regulation 26, no person shall supply a relevant device - 

unless that device meets those essential requirements set out in Annex 1 which apply to it.

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 - 

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 - 

    (4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national 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 - 

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 CE marking which - 

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

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 CE marking, meeting the requirements set out in Annex 9, appears on - 

and that CE marking is accompanied by any relevant notified 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 CE marking, meeting the requirements set out in Annex 9, appears on - 

and that CE marking is accompanied by any relevant notified 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 - 

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.

CE marking of active implantable medical devices that come within the scope of more than one Directive
     25. Where a relevant device comes within the scope of Directive 90/385 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 also satisfied, except where - 

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 Directive 90/385 or 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 CE marking, where appropriate subject to conditions (which are complied with), and has not withdrawn that authorisation.

Procedures for affixing a CE marking to active implantable medical devices
     27. A relevant device may bear a CE marking only if its manufacturer or his authorised representative - 

Procedures for custom-made active implantable medical devices
     28. 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 his authorised representative - 

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 the United Kingdom unless, before he does so, the manufacturer of the device or his authorised representative has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, in the form of - 

    (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 his authorised representative 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 authorised representative (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 his authorised representative pursuant to paragraph (1), give written notice to the manufacturer or his authorised representative - 

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

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

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 his authorised representative, shall - 

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

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

and if a clinical investigation is conducted in respect of a relevant device, the manufacturer of that device or his authorised representative shall keep available for the Secretary of State the report referred to in Section 2.3.7 of Annex 7.

Manufacturers etc. and conformity assessment procedures for active implantable medical devices
     30.  - (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 90/385 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 90/385 at an intermediate stage of manufacture of the device.

UK notified bodies and the conformity assessment procedures for active implantable medical devices
     31.  - (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 - 

    (2) Where a UK notified body takes a decision in accordance with Annex 2 or 3, 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 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 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, unless the context otherwise requires - 

    "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 European Communities;

    "device for self-testing" means an in 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, unless the context otherwise requires, 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 of in vitro diagnostic medical devices and accessories to such devices, except for - 

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

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 - 

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 if the device may reach a final user in the United Kingdom, unless - 

    (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.

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 CE marking which - 

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

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 - 

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 - 

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 - 

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.

CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive
     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 - 

In vitro diagnostic medical devices not ready for use
     38. Subject to regulation 39, no person shall - 

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 - 

    (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.

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 CE marking only if its manufacturer or his authorised representative - 

    (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 - 

    (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 - 

    (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 - 

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

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[19].

    (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 in the United Kingdom, provide the Secretary of State with the data referred to in article 12(1)(a), and that data shall be provided in English.

UK notified bodies and the conformity assessment procedures for in vitro diagnostic medical devices
     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 - 

    (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 evaluation
     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 - 

Registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation
     44.  - (1) Subject to paragraph (3), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person to whom this paragraph applies shall give the Secretary of State the following information - 

and shall notify him of any significant change to that information including discontinuation of the placing on the market of the device.

    (2) Paragraph (1) applies to - 

    (3) Registration under this regulation is not required if - 



PART V

Notified Bodies, Conformity Assessment Bodies and Marking of Products

Designation etc. of UK notified bodies
     45.  - (1) The Secretary of State may designate for the purposes of article 11 of Directive 90/385, article 16 of Directive 93/42 or article 15 of Directive 98/79 any corporate or other body as a body which is to carry out any of the tasks of a notified body, and, if he so designates a body (referred to in these Regulations as a "UK notified body"), he shall designate the tasks which it is to carry out.

    (2) A body may be designated under paragraph (1) as a body which is to carry out tasks of a notified body only if - 

    (a) in so far as it is to be designated as a body which is to carry out tasks included in Directive 90/385, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex 8 of that Directive are met;

    (b) in so far as it is to be designated as a body which is to carry out tasks included in Directive 93/42, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex XI of that Directive are met;

    (c) in so far as it is to be designated as a body which is to carry out tasks included in Directive 98/79, it is a body in respect of which the criteria for the designation of notified bodies set out in Annex IX of that Directive are met; and

    (d) in so far as it needs to be able to fulfil the functions of an importing Party arising out of the Mutual Recognition Agreements, it is able to do so.

    (3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

    (4) The Secretary of State may vary the tasks that a UK notified body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

    (5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if - 

    (a) the body so requests;

    (b) he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42 or Annex IX of Directive 98/79 are met; or

    (c) he considers that the body is not capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

    (6) Before - 

    (a) effecting a variation under paragraph (4); or

    (b) restricting or withdrawing a designation under paragraph (5),

otherwise than at the notified body's request, the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made.

    (7) For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of - 

    (a) any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

    (b) any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

    (8) The Secretary of State may request that a UK notified body supply to him any or all relevant information and documents, including budgetary documents, necessary - 

    (a) to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, or Annex IX of Directive 98/79; or

    (b) for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the body shall supply to him any and all relevant information or documents so requested.

Choice of notified bodies and conformity assessment bodies
     46. Where a conformity assessment procedure involves the intervention of a notified body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or his authorised representative may apply to any notified body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.

General matters relating to UK notified bodies
     47.  - (1) A UK notified body to which an application has been made by a manufacturer or his authorised representative to perform the functions of a notified body under a conformity assessment procedure set out in the Medical Devices Directives shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

    (2) Where a manufacturer or his authorised representative has supplied information or data to a UK notified body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

    (3) The information, data and correspondence that a manufacturer or his authorised representative supplies to a notified body in the course of a conformity assessment procedure set out in the Medical Devices Directives shall, if the notified body is within the United Kingdom, be in English or some other Community language acceptable to the notified body concerned.

    (4) A UK notified body shall, as respects a medical device which it has assessed other than an active implantable medical device, inform all other notified bodies and the Secretary of State of - 

and shall also make available to them, on request, any or all additional relevant information.

    (5) Where a UK notified body finds, as respects a medical device which it has assessed other than an active implantable medical device, that - 

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the notified body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the notified body shall inform the Secretary of State thereof.

    (6) The Secretary of State may request that a UK notified body supply to him any information and documents that the Secretary of State may, having regard to the terms of the Mutual Recognition Agreements, need to supply to a Party to the Mutual Recognition Agreements, and the body shall supply to him any and all information or documents so requested.

    (8) A UK notified body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under the Mutual Recognition Agreements.

Designation etc. of EC conformity assessment bodies
     48.  - (1) The Secretary of State may designate for the purposes of the Mutual Recognition Agreements any corporate or other body as a body which is to carry out any of the tasks of a European Community conformity assessment body, and, if he so designates a body (referred to in these Regulations as an "EC CAB"), he shall designate the tasks which it is to carry out.

    (2) A body may be designated under paragraph (1) as a body which is to carry out tasks of an EC CAB only if the Secretary of State considers that the body is capable of fulfilli