Summary of safety and clinical performance: MDCG Update

The MDCG has updated its Guidance on the Summary of Safety and Clinical Performance (SSCP), which is especially relevant for manufacturers of Class III and implantable devices that will need to make SSCP publicly available via EUDAMED.

Revision of the Guidance concerns:

• The text has been modified:

In Eudamed, the SSCP is associated to one unique Basic UDI-DI (previously: one unique or multiple Basic UDI-DI). All UDI- DIs/devices associated to this Basic UDI-DI will be seen as having the same SSCP (a UDI-DI/device must always be associated with one and only one Basic UDI-DI).

• The text has been added:

General requirements and recommendations for SSCP

The manufacturer will assign to the SSCP an identifier (reference number) that within the manufacturer’s management system is unique to that SSCP and will remain the same for the entire lifetime of the SSCP. In combination with the manufacturer’s SRN this will allow for the unique identification of the SSCP in EUDAMED and in EU.

• The text has been added at the beginning of the template:

Manufacturer’s reference number for the SSCP

More information on the Guidance can be found in our previous post. The entire text of the document, including the Template for the SSCP can be found at this link.

More documents released by the MDCG can be retrieved from our MDLaw Library of Documents.