The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year.
The European Commission intends to submit a proposal to the European Parliament and to the Council in early April 2020 to postpone entry into application of the MDR by one year. It has asked that the Institutions adopt the proposal quickly. This is particularly important in light of the fact that the MDR is intended to enter into application on 26 May 2020.
The proposed postponement of entry into application of the MDR is likely to be welcomed by the national competent authorities of many EU Member States as well as by manufacturers and notified bodies. There is not, however, an automatic presumption that the postponement will be accepted since there may be some EU Member State opposition.
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