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April 3, 2020

European Commission Postpones Medical Devices Regulation by 1 Year to Prioritize COVID-19 Response

April 3, 2020—The European Commission (EC) announced the adoption of a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by 1 year to allow European Union (EU) member states, health institutions, and economic operators to prioritize the fight against the coronavirus pandemic.

The EC advised that this 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.

The proposal postpones, for exceptional reasons in the current context, the application of the MDR until May 26, 2021. The proposal needs the full support of the European Parliament and the Council through an accelerated codecision procedure.

The EC announcement stated, "As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation."

According to the EC, although the new MDR 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. In addition, the proposal ensures that Member States and the EC can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU-wide derogations.

Furthermore, the EC noted to safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the EC Directive on active implantable medical devices and the Directive on medical devices by 1 year. This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes effective on May 26, 2022.

The adopted proposal is available here. The Medical Devices Regulation is available here. The April 3 announcement from the EC can be viewed here.

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