European Commission welcomes the MDR delay adoption by the European Parliament and the Council
Medical devices can be sold for another year under the current regulatory framework based on the EU Medical Device Directive (93/42/EEC).
The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone by one year the date of application of the Medical Devices Regulation.
This will allow Member States, health institutions and economic operators to give priority to the fight against the ongoing COVID-19 pandemic.
The adopted amendment takes into consideration the need for an increased availability of vitally important medical devices across the EU, and at the same time continues to guarantee patient health and safety until the new legislation becomes applicable.
For more details, please see the press release from the European Commission.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
