http://www.legislation.gov.uk/uksi/2002/618/contents/made

The Medical Devices Regulations 2002

Consumer protection

European Union

European Parliament

King's Printer of Acts of Parliament

2015-04-27

CONSUMER PROTECTION

These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93/42/EEC concerning medical devices, as amended; and Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices (“the Medical Devices Directives”). They also contain the legislative measures necessary for the implementation, in relation to medical devices, of the agreements on mutual recognition between the European Community and Australia, New Zealand, Canada and the United States of America—and of the Association Agreement between the European Communities, and their Member States, and Hungary.

The Medical Devices Regulations 2002

Pt. 8

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 10

reg. 1(1)

The Medical Devices Regulations 2002

Pt. 9

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 11

reg. 1(1)

The Medical Devices Regulations 2002

Pt. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(7)

reg. 1(1)

The Medical Devices Regulations 2002

Pt. 3

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(7)

reg. 1(1)

The Medical Devices Regulations 2002

Pt. 4

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(7)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 1A

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(2)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(3)(c)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(3)(c)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(3)(q)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(3)(q)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(3)(q)(iii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 2

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(3)(v)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 3 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(5)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 3

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 3(5)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 4D(10)(b)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 2(3)(a)

reg. 1

The Medical Devices Regulations 2002

reg. 4E(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 2(3)(b)

reg. 1

The Medical Devices Regulations 2002

reg. 6(d)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 4(2)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 7(2)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 4(3)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 12(6)

(7)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 4(7)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 17(3)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 4(8)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 18

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 4(9)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 26(4)

(5)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 5(5)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 30(4)

(5)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 5(6)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 31

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 5(7)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 33(1)(c)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(2)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 33(2)(c)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(2)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 35(2)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(4)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 39(3)

(4)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(5)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 41(5)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(6)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 41(5)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(6)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 42

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 6(7)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 45 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(2)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 45

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(2)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 45(1)-(3)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(2)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 45(5)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(2)(d)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 45(5)(c)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(2)(d)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(1)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(a)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(1)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(a)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(3)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(b)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(3)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(b)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(3)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(b)(iii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(5)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(6)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(d)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 47(8)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(3)(d)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48 heading

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(1)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(2)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(2)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(4)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(5)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(5)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(6)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(8)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(8)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 49 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(5)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 49

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(5)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 49

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(5)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 49 heading

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 49(1)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(5)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 49(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 49(1)(a)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 49(1)(b)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 49(1)(b)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 49(3)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 49(4)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(3)

reg. 1

The Medical Devices Regulations 2002

reg. 53

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(2)(a)

reg. 1(2)(d)

The Medical Devices Regulations 2002

reg. 53

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(2)(b)

reg. 1(2)(d)

The Medical Devices Regulations 2002

reg. 54 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(3)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(3)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(1)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(3)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(3C)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(3)(d)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(4)(a)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(3)(e)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(4)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(4)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(3)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(4)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 58(2)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(5)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 58(2)(a)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(5)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 58(2)(b)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 8(5)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 60(4)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 9(3)(d)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 61(8)(a)(i)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 9(4)(a)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 61(8)(a)(ii)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 9(4)(a)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 61(8)(b)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 9(4)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 75(3)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 9(2)(a)

reg. 1

The Medical Devices Regulations 2002

reg. 75(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 9(2)(b)

reg. 1

The Medical Devices Regulations 2002

reg. 93(4)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 9(3)

reg. 1

The Medical Devices Regulations 2002

reg. 119(6)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 9(4)

reg. 1

The Medical Devices Regulations 2002

reg. 124(5)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 9(5)

reg. 1

The Medical Devices Regulations 2002

reg. 149(5)(e)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 10(2)

reg. 1

The Medical Devices Regulations 2002

reg. 158(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 10(3)(a)

reg. 1

The Medical Devices Regulations 2002

reg. 158(3)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 10(3)(b)

reg. 1

The Medical Devices Regulations 2002

Sch. 19

para. 5

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 11(2)(a)

reg. 1

The Medical Devices Regulations 2002

Sch. 19

para. 5

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 11(2)(b)

reg. 1

The Medical Devices Regulations 2002

Sch. 24 para. 1(7) heading

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 11(3)(a)

reg. 1

The Medical Devices Regulations 2002

Sch. 24

para. 1(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 11(3)(b)

reg. 1

The Medical Devices Regulations 2002

reg. 60A-60C

Medicines and Medical Devices Act 2021

Sch. 3

para. 1

s. 50(3)

The Medical Devices Regulations 2002

reg. 60A

Medicines and Medical Devices Act 2021

Sch. 2

para. 4

s. 50(3)

The Medical Devices Regulations 2002

reg. 60A

Medicines and Medical Devices Act 2021

Sch. 2

para. 5(2)

s. 50(3)

The Medical Devices Regulations 2002

Sch. 3

Medicines and Medical Devices Act 2021

Sch. 3

para. 2

s. 50(3)

The Medical Devices Regulations 2002

reg. 54(1)(a)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(2)(a)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(1)(b)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(2)(a)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(2)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(2)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(3)(a)-(c)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(2)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 54(3A)

(3B)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(2)(d)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(1)(a)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(3)(a)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(1)(b)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(3)(a)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(2)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(3)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(3)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(3)(c)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(3)(a)-(d)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(3)(c)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 55(3A)-(3D)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(3)(d)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 56(1)(a)(i)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(4)(a)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 56(1)(a)(ii)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(4)(a)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 56(1)(b)(i)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(4)(b)(i)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 56(1)(b)(ii)

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

reg. 13(4)(b)(ii)

reg. 1(1)

The Medical Devices Regulations 2002

PART IIntroductory Provisions Relating to all Medical Devices

1Citation and commencement

2Interpretation

3Scope of these Regulations

4Transitional provisions

PART IIGeneral Medical Devices

5Interpretation of Part II

6Scope of Part II

7Classification of general medical devices

8Essential requirements for general medical devices

9Determining compliance of general medical devices with relevant essential requirements

10CE marking of general medical devices

11CE marking of general medical devices that come within the scope of more than one Directive

12Exemptions from regulations 8 and 10

13Procedures for affixing a CE marking to general medical devices

14Procedures for systems and procedure packs, and for devices to be sterilised before use

15Procedures for custom-made general medical devices

16Procedures for general medical devices for clinical investigations

17Manufacturers etc. and conformity assessment procedures for general medical devices

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

19Registration of persons placing general medical devices on the market

PART IIIActive Implantable Medical Devices

20Interpretation of Part III

21Scope of Part III

22Essential requirements for active implantable medical devices

23Determining compliance of active implantable medical devices with relevant essential requirements

24CE marking of active implantable medical devices

25CE marking of active implantable medical devices that come within the scope of more than one Directive

26Exemptions from regulations 22 and 24

27Procedures for affixing a CE marking to active implantable medical devices

28Procedures for custom-made active implantable medical devices

29Procedures for active implantable medical devices for clinical investigations

30Manufacturers etc. and conformity assessment procedures for active implantable medical devices

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

PART IVIn Vitro Diagnostic Medical Devices

32Interpretation of Part IV

33Scope of Part IV

34Essential requirements for in vitro diagnostic medical devices

35Determining compliance of in vitro diagnostic medical devices with relevant essential requirements

36CE marking of in vitro diagnostic medical devices

37CE marking of in vitro diagnostic medical devices that come within the scope of more than one Directive

38In vitro diagnostic medical devices not ready for use

39Exemptions from regulations 34, 36 and 38

40Procedures for affixing a CE marking to in vitro diagnostic medical devices

41Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices

42UK notified bodies and the conformity assessment procedures for in vitro diagnostic medical devices

43Devices for performance evaluation

44Registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation

PART VNotified Bodies, Conformity Assessment Bodies and Marking of Products

45Designation etc. of UK notified bodies

46Choice of notified bodies and conformity assessment bodies

47General matters relating to UK notified bodies

48Designation etc. of EC conformity assessment bodies

49Fees charged by UK notified bodies and EC conformity assessment bodies

50Products incorrectly marked with a notified body or conformity assessment body number

51Products incorrectly marked with a CE marking

PART VIFees charged by the Secretary of State

52Interpretation of Part VI

53Fees in connection with the registration of devices and changes to registration details

54Fees payable in connection with the designation etc. of UK notified bodies

55Fees payable in connection with the designation etc. of EC conformity assessment bodies

56Fees payable in relation to clinical investigation notices

57Unpaid fees

58Waivers, reductions and refunds

PART VIIGeneral, Enforcement and Miscellaneous

59Interpretation of Part VII

60Designation etc. of authorised representatives

61Enforcement etc.

62Compliance notices

63Restriction notices

64Notification of decisions etc.

65Centralised systems of records etc.

66Revocations

SCHEDULE 1ASSOCIATION AGREEMENTS

1The Protocol to the Europe Agreement establishing an Association between...

SCHEDULE 2MUTUAL RECOGNITION AGREEMENTS

1The agreement on mutual recognition in relation to conformity assessment...

2The agreement on mutual recognition in relation to conformity assessment...

3The agreement on mutual recognition between the European Community and...

4The agreement on mutual recognition between the European Community and...

2002 No. 618

CONSUMER PROTECTION

The Medical Devices Regulations 2002

Made20th May 2002

Laid before Parliament21st May 2002

Coming into force13th June 2002

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 19721 in relation to measures relating to medical devices2, 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 19733, in exercise of the powers conferred by sections 11 and 27(2) of the Consumer Protection Act 19874, 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:—