The European Commission has submitted a proposal to the European Parliament and to the Council for a Regulation amending Regulation (EU) 745/2017 on medical devices. The purpose of the amendment is to defer application of the Medical Device Regulation by one year. This includes postponement of the repeal of Directives 90/385/EEC and Directive 93/42/EEC for which the Regulation provides and extension of the validity of national derogations authorized under those Directives.
The proposal, which was published on 3 April 2020, acknowledges that the COVID-19 outbreak and the related public health crisis presents an unprecedented challenge to the EU Member States, national authorities, health institutions, economic operators as well as to EU citizens.
The proposal emphasizes that, under these exceptional circumstances, there is an increased need for resources and medical devices of vital importance, which could not have been reasonably anticipated at the time of adoption of Regulation EU 745/2017 on medical devices (MDR). The postponement of entry into force of the MDR and of repeal of the Medical Device Directive and the Active Implantables Directive are intended to safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020. The proposal is also intended to ensure that the European Commission is, in exceptional cases, able to adopt EU-wide derogations in response to national derogations at the earliest possible date in order to address potential EU-wide shortages of vitally important medical devices in an effective manner. Specific reference is made in the preamble to the proposal to the crucial role played by medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of EU citizens and to enable EU Member States to give patients urgently in need the necessary medical treatment.
If the proposal is adopted in its present form the MDR will enter into application on 26 May 2021 rather than the date of 26 May 2020 provided in the Regulation. The Medical Device Directive and the Active Implantables Directive will remain applicable during this period. The validity of national derogations from the obligation to CE mark medical devices that were authorized under these Directives will also be extended.
Among the revisions to the MDR included in the proposal is postponement of the obligation imposed on EU Member States to adopt, and notify the European Commission of, national rules established concerning penalties applicable for infringement of the provisions of the MDR from 25 February 2020 to 25 February 2021.
Revisions are also proposed to the transitional provisions provided in Article 123 of the MDR.
The European Commission has underlined the importance of having the proposal adopted and of the new Regulation entering into force before 26 May 2020.