Module 16 2024

17/10/2024

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

• Article 15, Person responsible for regulatory compliance

3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

The PRRC is responsible for ensuring the PMS requirements of the Regulation are met.

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

• Article 32, Summary of safety and clinical performance

2. The summary of safety and clinical performance shall include at least the following aspects:

(f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up [PMCF]

PMCF is a key aspect of PMS.

For Implantable and Class III devices relevant information from PMCF must be published in the SSCP.

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