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.
◷
New version applies from 24/04/2020.
125 provisions change.
Later versions: 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.