The MDCG have published a template for the Summary of Safety and Performance (SSP) as required by the EU IVD Regulation 2017/746 (IVDR) for Class C and Class D devices. The format of the SSP will depend on whether the device used is intended for self-testing. If it is not, then there shall be another section added specific to the professional user. For self-testing IVDs, the SSP shall be written in such a way as to be clear to the intended patient/user.
It is strongly recommended that Class C and Class D IVD manufacturers incorporate this template as it is likely that your Notified Body will be looking for the SSP to be provided in accordance with this guidance.
