The UK Government has recently made available a draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 (2023 Regs). Although these are far ...

Reforms to the EU’s medical device laws came into force on May 26, 2021, as the previous Medical Devices Directives (MDD) were upgraded to the more stringent and legally binding Medical Devices ...

The European Commission’s Medical Device Coordination Group (MDCG) has outlined the postmarket surveillance (PMS) requirements that medical device and in vitro diagnostic makers should adhere to as ...

In light of the disruptions caused by the COVID 19 pandemic, the postponement of the EU MDR brought a much needed respite to an already overstrained medical devices industry that already had been ...

Monitoring the safety of medical devices and pharmaceuticals after they enter the market is an essential responsibility for manufacturers. While the core purpose of Post Market Surveillance (PMS) is ...