The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press release reports, is to allow Member States, health institutions and economic operators to prioritise “the fight against the coronavirus pandemic”. As previously reported, the announcement follows the EC college (video) meeting on 25 March in which EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new MDR because of the global coronavirus pandemic.
According to the press release, the decision to delay “takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU while continuing to ensure patient health and safety until the new legislation becomes applicable”. The proposal, therefore, delays the application of the Regulation by one year (until 26 May 2021).
Additionally, the proposal also ensures that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations. However, the press release notes that the proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.
Vice-president for Promoting our European Way of Life, Margaritis Schinas, says: “Shortages or delays in getting key medical devices certified and on the market are not an option right now. The Commission is, therefore, taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic.”
Stella Kyriakides, commissioner for Health and Food Safety, adds: “Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible—by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”