Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach

Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition their products to the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which experts say could lead to devices being pulled from the EU market.

According to a recent survey by notified body industry group Team-NB, there is a growing gap between products that are set to lose their certification under the previous directives and those that have been recertified under the new regulations. The survey shows that while applications under MDR have increased from 1,661 in 2020 to 14,539 in 2023, the number of certificates issued in that time has grown from 180 to 4,873, leaving a gap of nearly 10,000 products awaiting certification.

One of the issues, according to the survey, is that most applications received have been incomplete to some degree, with approximately “75% of submitted files that are missing half of the needed information” necessary for the NB to start the assessment.

Over the past several years, the main concern in getting medical products recertified in the EU has been the capacity of notified bodies to handle the workload. The survey finds that for MDR, there were only 18 designated notified bodies in 2020, which has increased to 42 designated bodies in 2023. Similarly, for IVDR, there were only 4 designated notified bodies in 2020, which increased to 12 last year.

Similarly, IVDR notified bodies received 230 applications for certification in 2020 and were only able to certify 9 IVDs. Those numbers have increased to 1,565 applications in 2023, with 754 IVDs being issued certificates that year.

Gert Bos, executive director at Qserve, noted that the increasing gap between applications and certifications indicates much more work for notified bodies before the various MDR and IVDR deadlines. He also pointed out that the gap under MDR is much wider than that under IVDR and questioned why the number of applications coming in is still so low, especially for IVDs. While the timeframes for IVDR compliance have been extended, the MDR deadline for legacy devices is only a few days away on 26 May 2024.

“The European Commission and member states have tried to finish as many MDR application processes as possible before 26 May, so the last ones in the queue could potentially transfer legacy products towards MDR,” Bos told Focus. “Notified body growth came to a plateau a few years back, and apparently there are enough people to do the conformity assessments… but the major issue is the delay in getting dossiers to the notified body for review.”

Bos said that at the recent 2024 RAPS Euro Convergence conference in Berlin, he heard from notified bodies that they have been reaching out to clients to ask them to send their product dossiers as soon as possible.

“There does not seem to be a clear understanding of the massive procrastination to submit dossiers for review, but concerns on this situation are shared between notified body, commission, national authorities, hospitals and patient groups,” he said.

Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD, said that the notified bodies have received 20,242 MDR applications, which includes those that have gotten certified. However, she noted that there are more than 25,000 certificates for devices under the previous directive that are set to expire.

“Notified bodies are seeing a ‘catch up effect,’ with a lot of manufacturers applying shortly before the deadline of 26 May 2024,” she told Focus. “It’s uncertain if this ‘last minute’ wave of applications will make up for the observed deficit between MDD/AIMDD certificates and MDR applications observed in February 2024.”

Bos said he’s also concerned about the more than 10,000 directive certificates that needed to be recertified by the end of last year and hopes that since the data was gathered in the survey, more of those products have been recertified.

“Otherwise, the EU might be in trouble in the period to come, with potentially operating rooms closing in hospitals, and patient care generally being under pressure,” he added.

Hoekstra-van den Bosch noted that that number has indeed come down based the EU’s latest findings.

Some of the Team-NB survey's positive findings include the fact that MDR and IVDR review times have significantly reduced to around 12-18 months. Bos says he hopes they can go down to 6-12 months soon. The survey also found that notified bodies have significantly increased their workforce to handle the growing workload.

“Notified Bodies have hired in 2023 more technical resources to do conformity assessments in comparison to 2022 as well as more subcontractors with an increase of 10.2%,” said Team-NB. “Also, the number of hired administrative employees who support the process have increased by 22%.”

“That said today, the notified bodies are facing a difficult situation,” Team-NB added. “Some of the technical resources have a lack of work following the request of some manufacturers to put their application on hold or to delay responses.”

“Overall, we are moving in the right direction, but at this speed and with the number of submissions for review being below par, we might not get all products certified in time or it might actually be that there will be many older products that will be removed from availability,” said Bos. “With nobody centrally in control, this will lead to unforeseen situations of critical devices, such as surgical tools, not being available. Parties will have to work together to prevent this from happening, in the interest of the patients.”

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.

Team-NB survey

Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach

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