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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 Sch 2A para 7

Sch 2A para 7

In Annex 6— (a) in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”; (b) in Section 3 for “the competent national authorities” substitute “the Secretary of State”; (c) in Section 3.1 for “this Directive” substitute “the Regulations”; (d) in Section 3.2 for the fourth indent substitute— –the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied, (e) omit Section 5.

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