EU MDR deadline officially postponed to 2021 due to covid outbreak

by PQE Group

The European Council and Parliament have officially adopted an amendment to Regulation 2017/745, modifying the application dates of most of its provisions from May 2020 to May 2021.

This amendment – dated April 24 and published on April 23 on the Official Journal of the European Union — is intended to ensure the continuous availability of those Medical Devices that are crucially important for public health in the context of the COVID-19 outbreak, guaranteeing access to medical equipment for patients and health institutions who are urgently in need of intensive care ventilators, surgical masks, medical gloves, etc.

An unprecedented challenge, needing unprecedented solutions

Taking into account the magnitude of the current health crisis and the complexity of the Medical Device Regulation, the European Council and the Council of the European Union have approved of taking pressure off national authorities, notified bodies, manufacturers and other relevant parties that need to fully focus on the priorities posed by the global Coronavirus pandemic.

«The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to Member States and constitutes an immense burden for national authorities, health institutions, Union citizens, and economic operators. The public health crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745».

Not a “grace period”: manufacturers still to ensure EU MDR compliance on time.

While it is important to avoid market disruption and ensure the smooth functioning of the MD production cycle, it is also vitally important to note that this postponement should not be seen as a “grace period”. The deferment shall give the proper time for health institution, manufacturers, suppliers and other actors to prepare and ensure the implementation of the Medical Device Regulation’s guiding principles.

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