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 ...
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 ...
From May 26, 2020 onwards, medical device manufacturers operating and/or selling within the European Union must comply with the Medical Device Regulation (EU 2017/745), or “EU MDR”. This regulation’s ...
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