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The Post-Market Clinical Follow-up (PMCF) requirements under the European Medical Device Regulation: Step by Step PMCF

newsletter The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. More demanding for the manufacturers, the new Regulation (EU) 2017/745 is aiming to increase the safety and supporting innovation of the devices within the European Market.

Let’s start from the basics and try to understand these two quality processes: Post Market Surveillance (PMS) and Post-market Clinical Follow-up (PMCF) whose plan is an integral part of the PMS plan.

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The Post-Market Clinical Follow-up (PMCF) requirements under the European Medical Device Regulation: Step by Step PMCF

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