COVID-19: May 2020 application of the EU Medical Devices Regulation postponedMonday, 20 April 2020
The European Parliament, by urgent procedure on 17 April 2020, voted decisively to adopt the European Commissions’ proposal to delay the implementation of Regulation (EU) 2017/745, or the new Medical Device Regulation (the “MDR”), by one year in light of the COVID-19 pandemic.
The new MDR was due to be fully applicable by 26 May 2020. The proposal has now to be approved by the Member States and published in the Official Journal before it will enter into force. According to the European Parliament, those actions are expected at the latest by 26 May 2020 (the MDR’s original enforcement date). If approved by the Member States, the full application of MDR will now take effect on 26 May 2021.
The date of application of the In-Vitro Diagnostics Medical Devices Regulation is not affected by the new proposal and becomes applicable from 26 May 2022, as planned.
Pressure to postpone the implementation of MDR increased due to the worldwide impact of the COVID-19 pandemic and the current pressure on national health authorities and manufacturers of medical devices. In a press release issued by the European Parliament, available here, it noted that
“There is a fear there could be shortages or delays in getting the medical devices needed to fight COVID-19, were they to follow the new rules of the Medical Devices Regulation from May this year. The European Parliament is therefore supporting the proposal to postpone the application of this regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures."
The postponement of the MDR by the European Parliament will be widely welcomed given the intensifying burden medical device companies are presently facing in helping healthcare systems all over the world to overcome this outbreak, whilst managing the effects of the pandemic on their business operations.
Please note that the content of this summary does not amount to professional advice. Legal and tax advice should be sought in respect of specific queries. The COVID-19 situationis evolving rapidly and this update is provided on the basis of information available as at 20 April 2020.