Postponement of EU Commission Medical Devices Regulations
Some of the world’s largest economies may have started to re-open, but the coronavirus pandemic isn’t over yet. And the European Commission has taken stock: Member States, health institutions and economic operators will now prioritise the fight against the virus, thanks to a recent decision to postpone the application date of new Medical Devices Regulation. This new regulation was meant to come into force on 26 May 2020.
The decision to postpone the new regulation by one year takes into account the unprecedented challenges that the pandemic is posing to health authorities around Europe. It also reflects the need for a rapid increase in the availability of vitally important medical devices across the union, whilst continuing to ensure patient health and safety until the new legislation becomes applicable.
“Shortages (…) in getting key medical devices certified and on the market are not an option right now” explained Margaritis Schinas, Vice-President for Promoting the European Way of Life. “The Commission is therefore (…) 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.”
The proposal adopted last month postpones the application of the Regulation until 26 May 2021. Whilst the new Medical Devices Regulation remains key to ensure patient safety and increase transparency on medical devices across the EU, it is believed the currently applicable rules will continue to guarantee the protection of public health.
In addition, the proposal that was adopted ensures that Member States and the European Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner with EU wide derogations being introduced.
The current public health crisis is presenting a huge challenge that European union countries must face. It also represents a high burden for national authorities, health institutions and economic operators alike. This crisis created extraordinary circumstances that require substantial additional resources and an increased availability of essential medical devices, none of which could reasonably have been anticipated.
Stella Kyriakides, Commissioner for Health and Food Safety, explained: “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.”
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