Revision of Guide MDCG 2019-9 Rev.1 on the summary of safety and clinical performance

The Medical Device Coordination Group (MDCG) has just published the updated Guide MDCG 2019-9 Rev.1.

This March 2022 revision provides clarification in Section 3.1 on the association of the Summary of Safety and Clinical Performance Characteristics (SSCP) with the basic UDI-DI in EUDAMED and the addition of the manufacturer’s reference number in the general requirements and template.

As a reminder, the Medical Devices Regulation (EU) 2017/745 requires the manufacturer to provide public access to an updated summary of safety and clinical performance data (SSCP) for implantable devices and for Class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a Notified Body (NB) and made available to the public via the European Database on Medical Devices (EUDAMED).

The SSCP is intended to provide public access to an up-to-date summary of clinical data and other information on the safety and clinical performance characteristics of the medical device. It is an important source of information for the intended users, namely healthcare professionals and, where relevant, patients. It is one of several means to fulfill the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information.

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