Regulation (EU) 2017/745 Article 84

Post-market surveillance plan

Article 84

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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Other provisions in SECTION 1 — Post-market surveillance

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 84 of Regulation (EU) 2017/745 (LawPlayer, data as of 2026-07-04)

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