Proposal to delay MDR regulatory overhaul by one year adopted by European Commission
The European Commission has adopted a proposal to postpone the Medical Devices Regulation deadline as calls across the healthcare sector mount on European Regulatory Institutions to delay in the wake of the coronavirus pandemic.
Scheduled to come into force on the 26th May 2020 following a three-year transition period, MDR significantly changes many of the existing regulations relating to medical devices and is set to impact almost any company involved in the manufacturing, distribution or retail of medical devices.
With the deadline fast approaching, many companies had been racing to ensure compliance, however, have now shifted focus solely on meeting the increased demand for vital medical equipment across Europe has countries wrestle to control the COVID-19 outbreak.
In the midst of the continuing coronavirus crisis, many in the healthcare sector across Europe have lobbied European Regulatory Institutions to delay the deadline and, on the 25th March, European Commission spokesperson Stefan de Keersmaecker said the commission was looking to delay the “entry into force” of the new MDR.
On the 3rd April, the European Commission announced it has adopted a proposal which calls for the postponement of MDR until the 26th May 2021.
Discussing the proposal, 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.”
According to the European Commission, whilst the “new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health.”
The EC confirmed, however, that for the proposal to take effect, it “would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.”
