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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART III
- Regulation 21
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Scope of Part III
21. The requirements of this Part in respect of relevant devices apply in respect of active implantable medical devices and accessories to such devices, except for devices that come within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and
(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; and
(b)the manufacturer chooses to follow the set of arrangements in the other Directive.
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