Module 16 2024

10/17/2024

MDR - Art. 84 & Annex III: Post-market surveillance plan

The post-market surveillance system referred to in Article 83 shall be based on a product

[family] specific post-market surveillance plan.

For devices other than custom-made devices , the post- market surveillance plan shall be

part of the technical documentation specified in Annex III [ Technical Documentation on

Post-Market Surveillance]

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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MDR - Art. 84 & Annex III: Post-market Surveillance Plan

Shall address the collection and utilisation of available information, in particular: • Serious incidents and information including information from PSUR and FSCA

• Records of non-serious incidents and undesirable side-effects

• Information from Trend reporting

• Relevant specialist, literature, databases and/or similar registers

• Feedback and complaints – from Users, Distributors and Importers

• Public information about similar medical devices

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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