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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART III
- Regulation 25
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Changes over time for: Section 25
Version Superseded: 22/04/2011
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- 13/06/2002- Amendment
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CE marking of active implantable medical devices that come within the scope of more than one DirectiveU.K.
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—
(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;
(b)the manufacturer chooses to follow the set of arrangements in Directive 90/385;
(c)the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and
(d)the particulars of Directive 90/385, as published in the Official Journal of the European Communities, are given in the documents, notices or instructions accompanying the device, and in a manner in which those particulars are accessible without it being necessary to destroy the packaging which keeps the device sterile.
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