Module 16 2022

05/09/2022

• Chapter VII – Post-Market Surveillance, Vigilance and Market Surveillance • Annex III – Technical Documentation on Post-Market Surveillance • Annex XIV (Part B): Post Market Clinical Follow Up • Requirements are more prescriptive than MDD • New requirements for publicly available information and information sharing across Member States Post Market Surveillance & Vigilance – Requirements under MDR

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Post Market Surveillance

TERMINOLOGY

 Post Market Surveillance (PMS) – process of gathering information on a specific device or device family in the post-marketing phase, to monitor its clinical performance and establish if customer needs have been met.

The degree of PMS depends on:

 Device classification (risk)  Novelty of the device  Lifetime of the device PMS can be both proactive and reactive.

Manufacturers must have a PMS plan for each device,

aimed at identifying residual risks.  PMCF – inte ded to answer specific questions relating to clinical safety and performance (i.e. residual risks)

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