The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.
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Chapter VII · POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE › Section 1 · Post-market surveillance › Article 84
Post-market surveillance plan
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