Summary of Safety and Performance (SSP) (IVDR)
IVDR reference: Art. 29
Applicability: primarily class C/D (and other cases required by the Regulation)
Implementation note: while EUDAMED is not fully available, label or IFU must state where the SSP is available
Checklist
- [ ] SSP covers required safety and performance information and is consistent with PER / IFU
- [ ] Language and public accessibility arrangements meet requirements
- [ ] Label or IFU indicates how to obtain the SSP (EUDAMED or alternative)
- [ ] Change control: update SSP when safety/performance conclusions change materially
- [ ] Consistent with DoC, Basic UDI-DI and device identification