Transcription of 2002 No. 618 CONSUMER PROTECTION - legislation
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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. 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.
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
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