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Provision history · Medical Devices Regulation

Art. 84 · Post-market surveillance plan

Medical Devices Regulation · 32017R0745 · every version of this act · on EUR-Lex

1 change recorded across 1 version, newest first.

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Version detected Modified +1 −3

no amending act named

Applies from: no date changed

Explanation, written by a model and checked against the cited text

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

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version 32017R0745 → this version, detected 12 August 2026 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.