MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity
A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus.
The European Commission published a survey of data from notified bodies (NB) conducted by the Austrian National Public Health Institute (Gesundheit Österreich GmbH), and research groups Areté and Civic Consulting on 25 July. The survey provides an overview of the MDR/IVDR transition process as of the end of March 2023. The results show that compared to October 2022, the number of MDR/IVDR applications and certificates has increased significantly.
Between 22 October 2022 and 31 Marodiech 2023, the number of MDR applications rose more than 40% from 8,120 to 11,418. The number of MDR certificates also rose almost 50% during that time from 1,990 to 2951.
The survey found that in October 2022 there were 22,793 products on the market with valid certificates under the Medical Device Directive and Active Implantable Device Directive (MDD/AIMDD) which means that applications for about half of those products have been submitted for transition by March 2023, and about 35% of MDD/AIMDD products submitted for transition to MDR were submitted since October 2022.
Similarly, the data shows the number of IVDR applications received by NBs has gone up more than 15% from 822 in October 2022 to 950 in March 2023, and the number of certificates they have issued for the products has gone up 24% from 268 to 331 during the same period.
“This progress is good news, [but] the survey results should be interpreted with some caution,” Sabina Hoekstra-van den Bosch, global director for regulatory strategy at TÜV SÜD GmbH and vice-president of Team-NB, told Focus.
RELATED: An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)
While the survey takes into consideration data through 31 March 2023, Hoekstra-van den Bosch says it doesn’t take into account any potential effect of the MDR extension that went into effect on 23 March 2023. She says it is likely the effects of the delay are only now showing up in the data and notes NBs have shared new data through the end of June with the European Commission which may offer a clearer picture. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)
“Everyone hopes and expects, that the number of applications will increase rapidly,” said Hoekstra-van den Bosch. “[But] another expectation is that the number of certificates will rise much more slowly than the number of applications, as Regulation 2023/607 gives time until 2027/2028 to finalize certification, while in the meantime manufacturers are allowed to keep the legacy device on the EU market.”
Hoekstra-van den Bosch says calculating the transition rate for products getting MDR certified is complicated and can be interpreted differently.
She notes that the current number of AIMDD/MDD products that need to be recertified is probably being underestimated since under MDR certificates will need to be given out for products such as class IIb implantable devices that require separate certificates. On the other hand, grouping basic UDI-DI products under MDR may also mean an increase in the number of certificates.
Hoekstra-van den Bosch says the MDR extension and publication of a Medical Device Coordination Group (MDCG) guidance encouraging manufacturers to not wait until the last minute are all good signs and if left unheeded may still result in bottlenecks for products getting recertified. (RELATED: Euro Roundup: EU answers questions about the extension of MDR transition, removal of ‘sell off’ periods, Regulatory Focus 30 March 2023)
RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences
“The [Austrian National Public Health Institute] survey shows some hopeful signs, but the ‘proof in the pudding is the eating,’” Hoekstra-van den Bosch said. “We are eagerly anticipating the publication of the next editions of the European Commission’s survey results.”
Gert Bos, executive director of the Qserve Group, says his main concern about products transitioning to MDR/IVDR has to do with communication between NBs and manufacturers.
“On the one hand many notified bodies indicate they can handle more applications, whereas manufacturers are not all speeding up their processes to get to the application phase,” he told Focus. “Meanwhile, companies on their second and third dossier may currently be waiting for 12 to 18 months to get feedback on their responses to the previous rounds of questions.”
Bos says there is plenty of guidance on how the new MDR system should work but there is still not enough guidance on what is considered sufficient evidence regarding clinical support, toxicity, biocompatibility testing, and general performance testing.
“The good news is that the structured dialogues between manufacturers and notified bodies are starting to bring clearer expectations,” he added. “So, we are going slowly in the right direction.”
Bos is also concerned that when applications do get feedback from NBs, they may contain deficiencies that could have been addressed in the first review round.
The survey sheds some light on the topic and lists the key reasons for why an MDR application was refused and shows some interesting trends.
In October 2022, the top two reasons were insufficient NB resources or because the application was outside the scope of the NB’s designation, with 61 and 66 applications being refused for those reasons, respectively. However, the top three reasons given for an application refusal in March 2023 were the wrong qualification or classification of a product with 74 refusals, the application was not complete with 80 refusals and the application was outside the NB’s designation with 208 refusals.
The number of refusals due to insufficient NB resources dropped to 31 which shows that NBs have started to significantly increase their capacity to handle incoming applications.
Bos is also worried that while global production processes have significantly improved in the past three decades, it has come to a halt due to delays in the MDR transition process.
“The problems rise to the level that such reviews on supply chain and production change approvals are starting to take priority over the more lengthy full MDR review processes,” he said. “This might in the coming 12 months fill the spare notified body capacity, in which case we’ll be walking straight into a further bottleneck when too many MDR and IVDR applications come in the second half of next year.
“Again the message is clear: Don’t delay your MDR and IVDR applications, but talk with your notified body about having the elements of the continued improvement reviewed in parallel,” he added. “It might free up the blocked production processes and will be useful in the full application as part of the new production has already been reviewed by the notified body.”
Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.
© 2023 Regulatory Affairs Professionals Society.
- The Seven Steps to Performing FMEA - February 22, 2024
- Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization - February 20, 2024
- Secure by Design: A Crucial Imperative for Medical Device Teams - February 15, 2024