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…
