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Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)
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1.An extension of the scope of the notified body's designation may be granted in accordance with Article 3.
2.A designation as notified body may be renewed in accordance with Article 3 before the end of the validity period of the previous designation.
3.For the purposes of paragraph 2, the procedure set out in Article 3(2) shall include, where appropriate, an observed audit.
4.Extension and renewal procedures may be combined.
5.Notified bodies already designated before the entry into force of this Regulation and for which the designation does not have a stated validity period or has a validity period exceeding five years, shall be subject to renewal at least within three years of entry into force of this Regulation.
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