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.
If the device is not intended for self-testing, the SSP should have a first part dedicated to the professional user. When relevant , a second part dedicated to patients/lay persons should be added. It should be written in a way that is clear to lay
persons. The SSP template for devices not intended for self-testing is presented in Section 1.
If the device is intended for self-testing, the SSP should be written in a way that is clear to the patients/lay persons, for instance taking into consideration the age of the targeted population. The SSP template for devices intended for self-testing is presented in Section 2.