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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART III
- Regulation 22
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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—
(a)if that supply is also a placing on the market or putting into service of that device; or
(b)in circumstances where that device has also been placed on the market or put into service,
unless that device meets those essential requirements set out in Annex 1 which apply to it.
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