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2002 No. 618 CONSUMER PROTECTION - legislation

STATUTORY INSTRUMENTS2002 No. 618 CONSUMER PROTECTIONThe medical devices Regulations 2002 Made-----20th May 2002 Laid before Parliament21st May 2002 Coming into force - -13th June 2002 ARRANGEMENT OF REGULATIONSPART IIntroductory Provisions Relating to all medical Devices1. Citation and commencement2. Interpretation3. Scope of these Regulations4. Transitional provisionsPART IIGeneral medical Devices5. Interpretation of Part II6. Scope of Part II7. Classification of general medical devices8. Essential requirements for general medical devices9. Determining compliance of general medical devices with relevant essentialrequirements10.

STATUTORY INSTRUMENTS 2002 No. 618 CONSUMER PROTECTION The Medical Devices Regulations 2002 Made ---- - 20th May 2002 Laid before Parliament 21st May 2002

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Transcription of 2002 No. 618 CONSUMER PROTECTION - legislation

1 STATUTORY INSTRUMENTS2002 No. 618 CONSUMER PROTECTIONThe medical devices Regulations 2002 Made-----20th May 2002 Laid before Parliament21st May 2002 Coming into force - -13th June 2002 ARRANGEMENT OF REGULATIONSPART IIntroductory Provisions Relating to all medical Devices1. Citation and commencement2. Interpretation3. Scope of these Regulations4. Transitional provisionsPART IIGeneral medical Devices5. Interpretation of Part II6. Scope of Part II7. Classification of general medical devices8. Essential requirements for general medical devices9. Determining compliance of general medical devices with relevant essentialrequirements10.

2 CE marking of general medical devices11. CE marking of general medical devices that come within the scope of more than oneDirective12. Exemptions from regulations 8 and 1013. Procedures for affixing a CE marking to general medical devices14. Procedures for systems and procedure packs, and for devices to be sterilised beforeuse15. Procedures for custom-made general medical devices16. Procedures for general medical devices for clinical investigations17. Manufacturers etc. and conformity assessment procedures for general medical devices18. UK notified bodies and the conformity assessment procedures for general medicaldevices19.

3 Registration of persons placing general medical devices on the market1 PART IIIA ctive Implantable medical Devices20. Interpretation of Part III21. Scope of Part III22. Essential requirements for active implantable medical devices23. Determining compliance of active implantable medical devices with relevant essentialrequirements24. CE marking of active implantable medical devices25. CE marking of active implantable medical devices that come within the scope of morethan one Directive26. Exemptions from regulations 22 and 2427. Procedures for affixing a CE marking to active implantable medical devices28.

4 Procedures for custom-made active implantable medical devices29. Procedures for active implantable medical devices for clinical investigations30. Manufacturers etc. and conformity assessment procedures for active implantablemedical devices31. UK notified bodies and the conformity assessment procedures for active implantablemedical devicesPART IVin vitro Diagnostic medical Devices32. Interpretation of Part IV33. Scope of Part IV34. Essential requirements forin vitrodiagnostic medical devices35. Determining compliance ofin vitrodiagnostic medical devices with relevant essentialrequirements36. CE marking ofin vitrodiagnostic medical devices37.

5 CE marking ofin vitrodiagnostic medical devices that come within the scope of morethan one vitrodiagnostic medical devices not ready for use39. Exemptions from regulations 34, 36 and 3840. Procedures for affixing a CE marking toin vitrodiagnostic medical devices41. Manufacturers etc. and conformity assessment procedures forin vitrodiagnosticmedical devices42. UK notified bodies and conformity assessment procedures forin vitrodiagnosticmedical devices43. devices for performance evaluation44. Registration of manufacturers etc. ofin vitrodiagnostic medical devices and devicesfor performance evaluationPART VNotified Bodies, Conformity Assessment Bodies and Marking of Products45.

6 Designation etc. of UK notified bodies46. Choice of notified bodies and conformity assessment bodies47. General matters relating to notified bodies48. Designation etc. of EC conformity assessment bodies49. Fees charged by UK notified bodies and EC conformity assessment bodies50. Products incorrectly marked with a notified body or conformity assessment bodynumber51. Products incorrectly marked with a CE marking2 PART VIFees Charged by the Secretary of State52. Interpretation of Part VI53. Fees payable in connection with registration of devices and changes to registrationdetails54. Fees payable in connection with the designation etc.

7 Of UK notified bodies55. Fees payable in connection with the designation etc. of EC conformity assessmentbodies56. Fees payable in connection with clinical investigation notices57. Unpaid fees58. Waivers, reductions and refundsPART VIIG eneral, Enforcement and Miscellaneous59. Interpretation of Part VII60. Designation etc. of authorised representatives61. Enforcement Compliance notices63. Restriction notices64. Notification of Decisions Centralised systems of records66. RevocationsSCHEDULES1. Association Agreements2. Mutual Recognition AgreementsThe Secretary of State, being a Minister designated for the purposes of section 2(2) of theEuropean Communities Act 1972(a) in relation to measures relating to medical devices (b), inexercise of the powers conferred by the said section 2(2), in exercise, with the consent of theTreasury, of the powers conferred by section 56(1) and (2) of the Finance Act 1973(c), inexercise of the powers conferred by sections 11 and 27(2) of the CONSUMER PROTECTION Act1987(d)

8 , and in exercise of all other powers enabling him in that behalf, after consultation inaccordance with section 11(5) of the CONSUMER PROTECTION Act 1987 with organisationsappearing 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 SafetyCommission, hereby makes the following Regulations: PART IIntroductory Provisions Relating to all medical DevicesCitation and Regulations may be cited as the medical devices Regulations 2002 and shall comeinto force 13th June )( 1972 c. )( The Secretary of State was designated in relation to measures relating to active implantable medical devices in 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in 1993 )( 1973 c.

9 ( 1987 c. (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 otherthan that generated directly by the human body or by gravity; and(b) is intended to be totally or partially introduced into the human body (whethersurgically or medically, including being introduced into a natural orifice) and whichis intended to remain in the human body after completion of the surgical or medicalprocedure during which it is introduced,even if it is intended to administer a medicinal product or incorporates as an integral parta substance which, if used separately, would be a medicinal product.)

10 Association Agreement means an Agreement, listed in Schedule 1, establishing anAssociation between the European Communities and their Member States, on the onepart, and another State on the other part (referred to in these Regulations as a Statewhich is a Party to an Association Agreement ) on Conformity Assessment andAcceptance of Industrial Products; authorised representative means a person established within the Community or in aState which is a Party to an Association Agreement who, explicitly designated by themanufacturer, acts for the manufacturer and may be addressed by authorities and bodiesin 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 anin vitrodiagnostic medical device, theEuropean Community;(b) in the context of any requirement relating to any other medical device, the EuropeanEconomic Area.


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