- BSI said Monday its U.K. notified body now joins Dekra Germany as one of the two designated under the In Vitro Diagnostic Regulation.
- The company also said it's the first to achieve full scope designation, which means it covers all IVDs specified under the regulation, including cancer tests, genetic tests, physiological markers and companion diagnostics — products that did not require such review under the prior EU directive.
Meanwhile, the European Commission is reportedly planning to delay the implementation of Eudamed, which had been scheduled to go live in March 2020, until 2022, according to social media postings citing Commission officials speaking at a working group last week. Neither the Commission nor the European Union's Medical Device Coordination Group (MDCG) has issued an official statement.
The European landscape for medical device manufacturers is undergoing a wave of changes, with the Medical Device Regulation (MDR) taking effect May 26, 2020, and the In Vitro Diagnostic Regulation (IVDR) set to take force two years later.
The lack of designated notified bodies has limited manufacturers' ability to have products reviewed prior to the deadline.
In potentially bigger news, several EU MDR consultants on social media said the launch of Eudamed, a database which will be used to monitor the safety and performance of devices, is now expected to be delayed.
European Commission representatives were not available for immediate comment. But according to social media posts, the EC or MDCG is expected to confirm the delay by year's end. The information from Brussels was shared on the medical device forum in Hamburg, according to a post from Markus Pöttker, postmarket surveillance lead for the EU MDR programme.
"It's a nice surprise for all of us," Richard Houilihan of Eudamed Ltd. in Brussels told MedTech Dive Monday. "Hopefully, the industry won't waste time," he said.
The Eudamed project is expensive for companies in terms of time and resources, and it's particularly challenging in terms of IT resources.
In a social media posting, Houlihan advised industry to "view this delay as a gift."
"This is a real positive for the industry," he said, adding in the posting that companies with MDR Eudamed projects should "view this delay as an opportunity," he said.
Amid these changes, the MDCG said it was rolling out several guidances in multiple areas for the new regulations, regarding notified bodies, Eudamed, postmarket surveillance and and clinical investigation and evaluations.