EU MDR: Parliament overwhelmingly backs one-year delay

Regulatory NewsRegulatory News | 20 April 2020 |  By 

The European Parliament on Friday voted 693-1 with two abstentions to postpone the Medical Devices Regulation (MDR) by one year to 26 May 2021 two weeks after the European Commission proposed the delay in light of the disruption caused by the coronavirus disease (COVID-19) pandemic.
The proposal advanced by the Parliament includes changes to the Commission’s initial proposal drafted by the Council of the European Union on 7 April to apply the same delayed date of application to class I devices covered under Article 120(3) of the regulation. (RELATED: European Commission Seeks to Delay MDR by a Year, Regulatory Focus 25 March 2020; European Commission proposes to delay MDR by a year due to COVID-19, Regulatory Focus, 3 April 2020).
With the Parliament’s vote, the delay must now be approved by member states and published in the Official Journal of the European Union for it to take effect. In a statement, the Parliament said it expects those steps to take place by 26 May, when the regulation was initially slated to take effect.
“Given the current pressure on national health authorities and manufacturers of medical devices, there is a fear that 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 Parliament said.
The Parliament notes that the postponement only applies to the MDR and does not have any impact on the application of the In Vitro Diagnostic Regulation, which is still set to take effect on 26 May 2022.
European Parliament, Adopted Text


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy