The European Commission has adopted a proposal to postpone the application of the Medical Devices Regulation by one year, to allow Member States, health institutions, and economic operators to prioritise the fight against coronavirus.
The decision 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.
Margaritis Schinas, Vice President for Promoting our European Way of Life, said: “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, which is helping fight the pandemic.”
“This shows once again that the European Union is leaving no stone unturned in our support to national public health systems in their hour of need.”
Stella Kyriakides, Commissioner for Health and Food Safety, said: “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. Today’s decision is a necessary measure in these very exceptional times.”