Europe – Update : MDCG 2022-9 rev.1 – Summary of safety and performance template – April 2024

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires
that the manufacturer shall draw up a summary of safety and performance (SSP) for
class C and D devices, other than devices for performance studies. The SSP shall be
validated by a notified body (NB) and made available to the public via the European
database on medical devices (Eudamed).
Text elements in italic in the template are general information proposed to be included
in the SSP document.
The SSP should include information dedicated to the intended user, and if relevant, the
patient. The SSP shall be kept updated in Eudamed…