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EU’s MDCG Updates MDR Guidance

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU) has published an updated version of its guidance on the EU’s Medical Device Regulation ((EU) 2017/745, also known as the MDR) to provide clarification on specific documentation requirements applicable to Class III and implantable medical devices.

Published by the EU’s Director-General for Health and Food Safety, the updated guidance, MDCG 2019-9-Rev.1, “Summary of safety and clinical performance,” provides additional details on the MDR provision that requires manufacturers to identify each product-specific summary of safety and clinical performance (SSCP) with a unique manufacturer reference number.

Under the MDR, manufacturers are required to post SSCPs for the product to EUDAMED, the EU’s database for medical devices. The use of a unique manufacturer’s reference number in connection with a specific SSCP is intended to help improve more direct access to vital information for high-risk equipment and increase overall transparency.

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Read the updated MDCG guidance on the safety and clinical performance requirements applicable to Class III and implantable medical devices.

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