27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR

Regulatory NewsRegulatory News | 23 September 2019 |  By 

A new RAPS/KPMG survey of more than 200 medical device industry leaders found that only 27% said they will be fully compliant with the new EU Medical Devices Regulations (MDR) set to go into effect 26 May 2020.

Almost half of respondents also said they will likely discontinue or withdraw medical devices from the market because of the new regulation, and about half also said they will leverage the MDR’s transitional provisions to continue to sell their current devices in the EU through 2024 while working on their compliance programs.

Coinciding with the release of the survey’s results, experts gathered at RAPS’ Convergence in Philadelphia to discuss some of the pain points and next steps related to MDR and the in vitro diagnostic regulation (IVDR), which is set to take effect two years after MDR.

Duncan McPherson, clinical director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), told attendees that a proposal has been submitted to the European Commission for a second corrigendum to change the timetable for Class I reusable devices, including some software, that are being upclassified.

As others warned that this corrigendum is still in the proposal stage, McPherson said they are working on backup plans, too, if the Commission does not accept the corrigendum.

Meanwhile, experts warned of what’s to come. Bassil Akra, VP of notified body TÜV SÜD, explained how even if the European Commission designates 20 notified bodies by next May (four are currently designated), the workload will not be doable, especially as companies have to deal with the old and new regulatory systems simultaneously.

Akra also explained how the Commission guidance documents are adding requirements and burdens instead of explaining MDR. And for IVDR, no guidance has been released.

He also discussed how industry wants to know what are considered significant changes to devices in terms of MDR, but the Commission is not providing any answers. “So, we’re developing a kind of common interpretation among notified bodies, which we will circulate and publish,” Akra said.

Philippe Auclair, senior director for regulatory strategy at Abbott, added that he thinks other markets will be impacted by MDR as well, because so many companies use Europe as a launch base for markets worldwide.



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