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Apr 08

EMA ONE YEAR DELAY to (EU) 2017/745 Medical Device Regulation

Following their earlier communications, the European Commission (EC) have officially proposed for the 1-year delay of the (EU) 2017/745 Medical Device Regulation (MDR), with the new deadline being set for 26th May 2021.

To summarise their proposal, the EC have stated the reason for this delay is due to the impact the COVID-19 pandemic has had on the pharmaceutical industry, with foresight into the current May, 2020 deadline now being insufficient in allowing the appropriate stakeholders to readily prepare their processes and resources towards the successful implementation of this new regulation – which intended to greatly improve the supply, monitoring and control for safe usage of medical devices within Europe.

In addition to postponing the deadline of the (EU) 2017/745 MDR, the EC have also communicated, within their proposal, the necessity to defer the date of repeal for both 90/385/EEC and 93/42/EEC Directives with immediate effect, to ensure that a fully operational regulatory framework exists throughout this 1-year period.

Moreover, in regards to all works completed so far, the EC have stated that no further impact assessments will occur as a result of this proposed 1-year delay, as there is no intention to alter the regulation itself; nor introduce any budgeting implications or impede the usage of lawfully marketed medical devices prior to the new 26th May 2021 deadline.

In conjunction with their decision to proposedly postpone the MDR deadline, the EC have also alluded to an exception to the standardised 8-week confirmation period; in hope that a decision can be made before the current 26th May 2020 deadline, to allow for the necessary focus and channelling of resources into combating COVID-19 and the affiliated rise in demand for medical devices across the continent.

PharSafer will continue to monitor all updates directly from the European Commission and inform you of any further notifications, regarding European Medical Device Regulation, as we receive them.

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