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 . . .


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