The Importance of Post-Market Clinical Follow-up (PMCF)

Under the EU MDR, post-market surveillance (PMS) is a critical quality control measure designed to identify risks associated with a device after being used for some time. Post-market clinical follow-up (PMCF) is an important part of a manufacturer’s PMS and is used to:

• Verify the clinical performance of a product and confirm the safety
• Ensure the continued acceptability of the previously identified risks
• Detect new risks based on factual evidence

This whitepaper provides valuable insights and tips to help conduct an effective PMCF study to ensure that better, lower-risk products are being brought to market, reducing unavoidable residual risks to acceptable levels. 

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