NEW EU MEDICAL DEVICE REGULATIONS: BE AWARE OF THE CHANGES

摘要

On May 25th 2017, the new EU Medical Device Regulation and the EU In Vitro Diagnostics Regulation came into force. Now, medical device manufacturers (and businesses involved in these supply chains) have less than two years to comply in full to the former (26th May 2020) and four years to comply with the latter (26th May 2022). The European Commission expects the regulations to improve the quality, safety and reliability of medical devices, while also strengthening the transparency of information for consumers and enhancing the vigilance and market surveillance.