European Commission Seeks to Delay MDR by a Year
As COVID-19 continues to disrupt Europe and pull medical device companies in different directions, Stella Kyriakides, European Commissioner for Health and Food Safety, said Wednesday that the commission will propose to delay the implementation of the Medical Devices Regulation (MDR) by one year. MDR was due to apply from 26 May.If approved, the delay will come as a relief to device manufacturers. MedTech Europe on Monday called on the commission to pause the date of application for MDR and resume it six months after the present crisis has passed.
The Socialists and Democrats in the European Parliament also sent a letter on Tuesday calling for a postponement of MDR, saying: “Fewer resources are available to ensure the implementation of the regulation, for example, the approval of clinical studies, the designation and auditing of notified bodies and in manufacturing. We propose to maintain the current system and postpone the implementation deadline of 26 May 2020 to allow the industry focus on the essential and urgent work of tackling COVID-19.”
European Commission spokesman Stefan De Keersmaecker added in a Q&A on Wednesday on when such a delay might be proposed: "We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis.”
Gert Bos, executive director and partner at the Qserve Group, said the proposal still needs to be adjusted to also include wording on keeping the validity of the Medical Device Directive/Active Implantable Medical Devices Directive in the interim.
Questions about whether device companies and notified bodies would be ready by 26 May have lingered since at least last year, particularly on whether notified bodies would have enough capacity. Kyriakides said in December that the May deadline would not change but it appears the COVID-19 crisis has changed her mind.