Completion requirements
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1. Medical Device development and lifecycle management under the MDR and IVDR
1.4. Post Market phase
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- Post Market Surveillance (PMS) plan and process
- Market surveillance [1]
- Proactive post market clinical follow-up (PMCF)
- Continuous assessment of the risk management system (continuous iterative process over the entire lifecycle of a device, regular systematic updating), which will allow:
- the identification and analysis of the hazards associated with each device,
- estimation and evaluation of the associated risks,
- elimination or control of residual risks
- evaluation of the adopted measures based on the information collected from the post-market surveillance system.
[1] Definition: ‘Market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.
See Chapter VII, Section 3 of the MDR and IVDR for more information