Full text of EU MDR (Medical Device Regulation)
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EU MDR Table of Contents

Source EUR-Lex: https://eur-lex.europa.eu/
EU MDR Chapter 7 Section 1 Article 84

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 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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