EU device expert warns manufacturers not to wait until the last minute to transition their products
LINTHICUM HEIGHTS, MD – AN EU medical device expert advised manufacturers to avoid submitting applications at the last minute for approval under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), as delays can create trouble and potential bottlenecks in obtaining certifications.Gert Bos, the executive director and partner at Qserve Group, said that notified bodies are “screaming for work” and are laying off staff because there is not enough for them to do.
There will be “big trouble” if everyone waits until the last minute to submit applications, said Bos, who spoke at the RAPS Global Regulatory Strategy Conference on 12 March. At the meeting, Bos also discussed the evolving nature of MDR, IVDR, and notified bodies.
The EU has postponed specific aspects of the implementation of MDR and IVDR multiple times since the regulations went into effect in order to give manufacturers more time to bring products into compliance. The latest IVDR extensions shifted the transition deadline to 31 December 2027 for high-risk class D IVDs, 31 December 2028 for class C products, and 31 December 2029 for class A (sterile) and class B products.
MDR is now in effect for all class I and custom-made devices and will go into effect on 26 May 2026 for class III custom-made implants, while regulations governing class III and class IIB implantable will go into effect on 26 May 2027, and by 26 May 2028 for class IIB and IIA products.
Bos pointed out that with deadlines for some products years away, manufacturers lack the incentive to pursue marketing applications for their products during this interim period, which allows these devices to be marketed.
“Why would you rush your dossier through the notified bodies?” when there is a three-year window to get approval, said Bos.
Bos said that in the interim period “other regulatory work” takes priority. Yet this delay “pushes everything through to the last minute and by that time we will be in big trouble.”
“The frustrating part ... from the perspective of the notified bodies is that we keep postponing and postponing,” he said.
In the meantime, he said that notified bodies are over capacity, and they are “screaming for work and screaming for work to be submitted … Notified bodies are sitting on their hands and waiting for work.”
The current situation is dire, said Bos. “We are also hearing in the news that some notified bodies are starting to release staff. One kicked out 10% of their staff, and others are leaving, and they are not being replaced.”
Current estimates indicate that 70 to 80% of dossiers are prepared but have not been submitted. Bos urged manufacturers to turn this situation around.
He told the audience that “if there is anything you and your company can do to get your project going, then we can leave this beautiful transition period behind us.”
Despite some challenges faced by notified bodies, Bos highlighted that significant progress has been achieved in recent years to align their policies.
TEAM-NB, which consists of clinical experts, meets three to four times a year to discuss and achieve a consensus on issues related to clinical studies. One working group is meeting to achieve consensus on Article 61 of MDR on clinical studies. Other groups are discussing non-clinical data and well-established technology (WET).
Currently, there are 50 notified bodies under MDR and 13 notified bodies under IVDR. “There is now a sufficient choice and scope” in these organizations.
Bos said that the work of notified bodies is “so much better now” compared to the past when he used to work for one. He added that “we have achieved a lot of harmonization in the notified body” space.
