In late April 2020, the European Parliament has postponed the come-into-force of the EU Medical Device Regulation (MDR) by one year. Medical devices can thus be placed on the market for another year under the previous regulations. The end date of the transition period will remain May 26, 2024.
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.
The MDR was supposed to enter into force on May 26, 2020. Among other things, the regulation defines uniform and more stringent criteria for so-called notified bodies for the approval of medical devices and regulates the procedure for the approval of clinical trials of medical devices.
The EU Commission had already advocated postponing the MDR in March 2020 to avoid supply shortages of medical devices during the COVID-19 crisis.
The postponement of MDR will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from May 26, 2022.
The full details in English can be found here. The full text of the Medical Device Regulation can be found here.
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