Module 16 2024

17/10/2024

What are the post-market surveillance requirements of the MDR?

• Article 92, Electronic system on vigilance and on post-market surveillance

1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information… • Vigilance reports • Trend reports • PSUR’s • Field Safety Notices • Information to be exchanged between Competent Authorities, i.e., vigilance, recalls, FSNs, FSCAs, etc.

EUDAMED will become the PMS/Vigilance reporting system….Q4 2024?

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What are the post-market surveillance requirements of the MDR?

• Annex III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex…

Annex III defines the requirements for the PMS plan.

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