Medtech firms with a paper trail showing strong efforts to comply with the EU Medical Device Regulation may be able to negotiate regulatory flexibility if they can’t recertify their devices by the time the directive takes full effect in May 2020.
Even companies that have filed for renewal on time may find themselves in this position, as notified bodies are struggling to complete all of the recertifications by deadline due to the high number of submissions, Oliver Bisazza, director of regulations and industrial policy for MedTech Europe, said at the AdvaMed MedTech Conference in Boston.
Bisazza noted that companies have been taking significant steps to prepare for the regulation, diverting money from R&D and other activities, but are now wondering if they will have to go for a time without a CE mark.
“The advice was always ‘do as much as you can while you can. Be ready,’” he said. But that “doesn’t necessarily mean have all your CE marks in place if that’s beyond your control.”
If companies miss the deadline despite a good faith effort, they should be prepared to show regulators that they did all that could be reasonably expected. This includes finding a notified body, communicating with them regularly to stay on track and checking all technical files against MDR requirements.
“You need to be able to reassure them you have been making an honest go of it,” and if companies can demonstrate these efforts, “I like to think a reasonable regulator … is open to giving some kind of leniency,” said Bisazza.
Medicines and Healthcare products Regulatory Agency Director of Devices John Wilkinson, also on the panel, agreed that “authorities are sympathetic to people who are trying to hit the mark,” and that regulators aren’t in the game of stopping patients from receiving necessary products.
If device makers are “slightly short in certain areas but there is no patient safety or health issue, then we’re sympathetic and we’re willing to go with the flow -- probably,” he said.
Other issues discussed by the panel included:
- industry concerns related to a no-deal Brexit
- the shortage of human resource capacity to handle in vitro devices as the clock starts to tick for implementation of the EU In Vitro Device Regulation
- notified body prioritization of recertifications over new products leading to an “innovation pause.”
Panel moderator Angela Brown, director of regulatory affairs for ICON, assured attendees they are not alone in these concerns and urged them to seek help if they need it, whether from regulators, notified bodies trade associations or consultancies.
April Hollis is custom content editor for health care. She has been with SmartBrief since 2013 and has covered health care and life sciences topics since 2006.
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