EU confirms new medical devices regulation postponed until 2021
According to NS Medical Devices, new EU rules for medical device manufacturers have been postponed by a year in a bid to prevent shortages in getting key equipment on the market during the coronavirus pandemic. The Medical Devices Regulation (MDR) was due to be enforceable on 26 May 2020 but will now take effect on 26 May 2021, the European Parliament confirmed.
In a statement, the European Parliament said: “Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that there could be shortages or delays in getting the medical devices needed to fight Covid-19, were they to follow the new rules of the Medical Devices Regulation from May this year.