Convergence: Notified bodies provide proposals for MDR/IVDR changes

PITTSBURGH — Updates on the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are often associated with bad news. But experts at a recent session at the RAPS Convergence 2025 conference on MDR/IVDR updates wanted attendees to know that the news this year is positive.

The problems associated with MDR/IVDR that were “driving us crazy” in the past, such as finding notified bodies and creating an opportunity to talk to them, are no longer concerns, Bassil Akra, chief executive officer of AKRA TEAM, told attendees at the meeting. Currently, there are more than 30,000 applications for the MDR and 3,000 applications for IVDR, and about half are certified, he said.

“It's positive. We are moving, and we need you as well to help that movement to be faster,” Akra said. “Moving alone as a notified body doesn't work, so we need to work all together to make sure that we keep positive and keep achieving the target, which are the due dates.”

Notified bodies are also proposing a number of changes to improve harmonization and cost efficiency for stakeholders associated with the MDR/IVDR, Suzanne Halliday, vice president of regulatory and global regulatory compliance at BSI, told attendees. Notified bodies have met in a number of workshops and preparatory workshops where priority topics have been voted on. She noted that Team-NB and NBCG-Med are “working closely together.”

“[A]t the end of the day, we're all trying to do the same thing, which is to allow safe devices out as quickly as possible,” Halliday said.

Recent top priorities for notified bodies include adherence to timelines, simplifying the notified body coding system, fixing conflicting Medical Device Coordination Group guidance documents, and making conformity assessments more predictable. Other priority issues include improving recertification, and reducing the number of situations where vigilance is duplicated and reviewed multiple times by more than one person.

Some of these issues may be addressed through digitization, Halliday said. Digitizing aspects of the process such as labeling, technical documentation, information on certificates, and conformity assessment may help sure that “things come in once” in a structured and streamlined way,” she explained.

“We are in favor of all of our documentation being digital,” she said. “It should all be available in a in a digital way with a single source of truth, so that there's fewer inconsistencies, because it seems to waste notified body and manufacturer time if things are inconsistent in two different places.”

Notified bodies also want to be involved earlier in the process, Halliday noted. “We keep hearing how well the FDA do on pre-submissions and we seem to be excluded at the beginning, and it is hindering progress sometimes,” she said.

Halliday emphasized that this would not be the same as consultancy, but an opportunity for “understanding what’s coming, and what the path is, and what the classification is, or whether it needs a clinical investigation.”

Being involved early in the process would offer manufacturers certainty “to continue getting investment and make progress and hit milestones so that things happen for them in funding rounds,” she said.

The involvement of notified bodies would be confidential and monitored by authorities, she added. “Notified bodies are monitored all the time. We're not afraid to be monitored by the authorities,” Halliday said. “Watch what we're doing. We're not consulting. We can do this in a competent, impartial, confidential way.”

There is also a proposal for a streamlined designation process for notified bodies. Getting designated quickly allows for notified bodies to shift away from internal problems to helping manufacturers. “I think when there was a lack of notified bodies, it was because we were all very worried about our own designations and proving that we knew what we were doing, so we couldn't handle what the manufacturers needed from us because we were handling what we needed to do to stay in business,” Halliday said.

Halliday noted that there is also a proposal for a breakthrough pathway for devices, with designation granted from the European Commission or expert panels that include conditional certificates that have requirements for post-market evidence. She said that notified bodies would like to be involved when expert panels are talking with a manufacturer, and are seeking legal ways to identify breakthrough products.

“During the pandemic, we were allowed to prioritize things legally, and the rest of the time, we are told that we must behave in a way that everyone has equal access and things can't be prioritized,” she explained. “We can't have a favorite manufacturer. Of course not. We understand how to behave. But if there is a breakthrough product, is there a legal way it can jump to the top of our queues?”

Notified bodies are also considering changes to the validity of a notified body proposal certificate. The proposal would offer unlimited certificate validity contingent on periodic checkpoints of 5 years or shorter, which Halliday said could be accomplished digitally.

“We don't think the Member States will ever allow it to be removed entirely, but if EUDAMED is visible, can we remove expiry dates which then allow the certificates to remain there with a periodic check behind the scenes?” Halliday asked.

Halliday compared proposing these changes to “trying to revise the engine while the car is running.” Although nothing has changed yet, “there is still legislation we have to follow,” she said.

RAPS Convergence

Convergence: Notified bodies provide proposals for MDR/IVDR changes

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