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 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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New version applies from 25/05/2017.
124 provisions change.
Later versions: 24/04/2020, 11/03/2023, 20/03/2023, 09/07/2024, 10/01/2025, 01/01/2026, 19/07/2026.
Article 84 changes in this version: compare with the current text.