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