Compliance to General Safety and Performance Requirements of the new European Medical Device Regulations (EU-MDR & EU-IVDR) is demonstrated through Technical Documentation. The latter consists of various, ‘’dynamic’’, regulatory documents, which require periodic updates to prove the continuous safety and intended performance of medical devices.
To help organize your future tasks, we have summarized the mandatory reporting requirements under EU-MDR 2017/745 and EU-IVDR 2017/746 and the main mandatory vigilance reporting requirements in the following tables.
