EU Commissioner for Health: MDR’s May 2020 Deadline Won’t Change

Regulatory NewsRegulatory News | 09 December 2019 |  By 

Despite concerns raised by both the medical device industry and EU member states that the 26 May 2020 deadline for the Medical Devices Regulation (MDR) is unfeasible, European commissioner for health Stella Kyriakides said Monday that the deadline will not change.

Echoing her predecessor’s comments from last June, Kyriakides said at a press conference following the meeting of the EU’s Employment, Social Policy, Health and Consumer Affairs Council that “a lot of work needs to be done but we’re all working together and it’s going to be a rough road.”

She said she thought member states have been supportive of the process, although the US and others have sought a three-year implementation delay. And for some up-classified Class I devices, the second corrigenda for MDR may push back the deadline for compliance by four years.

“What I made very clear is that we’re fully committed that the target of May 2020 is enforced,” Kyriakides said. “There were concerns raised, especially because Eudamed will not be fully ready to run but this has been taken into consideration by the legislators so there are other strategies that will be implemented. So there are no plans to change the deadline. We will continue to work together to put the system into play.”

In discussions with the council, Kyriakides said over 700 experts have applied to serve on the new medical device expert panels.

“The crucial implementing acts,” such as on the standardization mandate and the reprocessing of medical devices “are close to being finalized,” she added.

The postponement of the Eudamed database does not impact the application of the regulations, “which is why there’s an alternative plan for the exchange information and we started working on the operational details of this plan,” Kyriakides said.

She also noted that another three notified bodies (NBs) are expected to be designated before the end of the year.

But there are still concerns about an insufficient number of NBs, and although the EC previously said 20 NBs would be designated by the end of 2019, that milestone is likely to not be met. Seven NBs have been designated so far under MDR (in addition to two under IVDR), including two Dutch NBs, Germany’s TÜV Rheinland, Italy-based IMQ IstitutoBSI UK, Germany-based TÜV SÜD and Germany-based Dekra Certification GmbH.

“I want you to know the [NB] designation process has been sped up and 12 designations have been completed and we hope that by the first quarter of 2020, we will get up to 20 designations,” Kyriakides said.

She added that she will keep informing the council and Medical Device Coordinating Group with regular updates on MDR.

Krista Kiuru, Finland's minister of education and science, added that both the device industry and member states are worried that certain central elements of the regulation are incomplete.

“Finland has similar worries as the other member states, but I actually felt we had a very fruitful discussion and that [Kyriakides] took seriously member state comments during the meeting,” Kiuru said.

Employment, Social Policy, Health and Consumer Affairs Council, 9-10 December 2019


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