The application of the EU Medical Device Regulation (the "MDR") has been postponed by a year, from 26 May 2020 to 26 May 2021. This postponement has been approved by the European Parliament and the Council of the European Union as of 23 April 2020 by way of Regulation 2020/561.
This postponement is exclusively driven by the challenging circumstances faced by public health systems, manufacturers of medical devices, and distributors / importers alike as a result of the current COVID-19 pandemic. EU legislators have recognised that stakeholders should be focusing their efforts on dealing with the current crisis and that compliance with the new standards to be imposed by the MDR should be deferred by a year.
Regulation 2020/561 specifically provides in its recitals that:
"Given the unprecedented magnitude of the current challenges, and taking into account the complexity of the [MDR], it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein".
The priorities are to avoid any shortages or delays in the supply to the internal market of essential medical devices, such as PPE and that new standards should not hamper the supply chain in any way.
It is perhaps interesting to note that, at least in one respect, the MDR has been amended to bring its application forward, rather than postpone it. The MDR provides for the possibility of a national or Union-wide derogation from the requirement that medical devices should be CE-marked in the interest of health protection, or in the interest of public health or patient safety or health. The application of these provisions on national or Union-wide derogations has been brought forward as of 24 April 2020 giving added flexibility to Member States and the European Commission at this time.
This one-year delay means that the current Medical Devices Directive and the Active Implantable Medical Devices Directive will continue to apply, until 26 May 2021. However, the date of application of the IVDR is not affected and will be applicable as of 26 May 2022.
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