detected 2026-08-12 MODIFIED+1 −3§
no amending act named
applies from: unchanged
The reference to the section of Annex III setting out the requirements for the post-market surveillance plan was changed from Section 1.1 to Section 1.
Cited: Art. 84, v1 · Art. 84, v2
text before / after
32017R0745 → 02017R0745-20170505
Article 84
Post-market surveillance plan
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 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.