With the expansion of the impact of the new coronavirus in the EU, it has posed unprecedented challenges to member states. In order to respond to the emergency needs of EU member states for medical devices, while avoiding the lack of compliance with existing medical devices Due to the risk of material shortages due to insufficient number of assessment institutions, the European Commission postponed the implementation of the new Medical Devices Regulation (MDR) by one year to May 26, 2021. The regulation was originally planned to take effect on May 26, 2020 to replace the old medical device regulations. Directive MDD.
This resolution is welcomed by medical device manufacturers and certification bodies that have not yet obtained MDR authorization. Due to time reasons, most MDD institutions have stopped accepting new MDD applications in the past two months. After this resolution, most MDD institutions will restart accepting certification. At the same time, it also provides sufficient transition time for MDD institutions to convert MDR.
Affected by the epidemic, the implementation of the EU Active Implantable Medical Devices Directive “Directive on active implantable medical devices” has been postponed for one year.
However, the above decision will not affect the effective date of the EU’s “InVitro Diagnostics Medical Devices Regulation”, which will take effect on May 26, 2022.
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