Experts: Notified body survey shows MDR/IVDR progress despite some snags

A recent survey shows progress in the number of applications being filed with notified bodies (NB) and certificates issued under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). However, there continues to be issues with applications that result in refusals from the NBs.

On 30 October, the European Commission released results of its tenth survey of NBs and how they have processed certifications and applications to transition products to the MDR and IVDR. It was conducted between January and June 2024 and provides a snapshot of the current medtech regulatory landscape.

Compared to June 2023, when NBs reported they had received 13,177 MDR applications and issued 3,899 certificates, the number of MDR applications a year later went up to 26,185 and NBs issued 8,905 certificates. The survey also broke down the kinds of MDR applications.

There has been a huge spike in QMS applications from 9,071 applications in June 2023 to 16,053 applications in June 2024, of which 5,925 have so far been given certificates. On the product side, NBs received 4,106 product applications by June 2023 which rose to 6,343 applications by June 2024, of which 2,980 have been issued certificates.

Similarly, the number of IVDR applications went up from 1,155 to 1,747 between June 2023 and June 2024. The number of IVDR certificates also went up in that timeframe from 500 to 940.

“It’s encouraging to see a continued increase in applications made to NBs and in certificates issued across both the MDR and IVDR,” Graeme Tunbridge, a senior vice president at BSI, told Focus.

“What stands out is that for the first time the number of applications for the MDR (26,185) is greater than the number of MDD/AIMDD certificates that were valid in April 2022 (25,034),” he added. “Of course, there is not a straightforward correlation between historic MDD/AIMDD certificates and MDR applications, but it’s a clear indication that good progress is being made in the transition to the MDR.”

Tunbridge, however, said he’s disappointed that there isn’t a continued downward trend in time to certification. He said previously it could be attributed to manufacturers and NBs familiarizing themselves with the new legislation.

The survey found that 67% of IVDR QMS certificates took six months to a year, and 17% took between 13 to 18 months. Almost three-in-five IVDR QMS certificates that also included product certificates, took 13 to 18 months, and 17% of them took 19 months to two years.

Similarly, the survey found that two-thirds of MDR applications took two months or less to get a written agreement. On the other end, 873 MDR applications took more than six months to get a written agreement.

“It is likely that this reflects the impact of the extension of the MDR as NBs are seeing manufacturers enter into agreements but are delaying submitting technical documentation until much closer to the new deadlines,” said Tunbridge. “This will be challenging for NBs to manage as we do not want to see a further bottleneck around the 2027 and 2028 deadlines.”

While NBs have struggled for years to build capacity, over the past few years they have voiced confidence that they currently have the capacity to handle the applications and need manufacturers to bring their applications sooner rather than later.

“It is important that a range of high-quality NBs are available across the EU to be able to support the wide range of manufacturers that wish to enter the EU market, however additional NBs at this stage are not critically needed to add capacity to the system,” said Tunbridge. “The key challenge now is how to drive a harmonized, streamlined approach across all of the NBs to ensure that manufacturers experience consistent and high-quality conformity assessments.”

Gert Bos, executive director at Qserve, told Focus that NBs have the capacity to handle the workload.

“My key concern is that still two-thirds of the applications need to be reviewed, and whereas many thought that once all now went through the application review and are ready to be submitted, notified bodies indicate they start having a lack of work,” said Bos. “So other factors are at play here, that are not always clear.”

Tunbridge noted that BSI has been publishing its lead times for conformity assessments starting earlier this year which demonstrates that it has the capacity to deliver conformity assessments across most technical areas.

Tunbridge said that while it is a priority to bring down timelines to certification, stakeholders may need to gather more data to understand how legacy medical device directive (MDD) products are affecting the timelines. In particular, he said it may be worth looking at how long it takes first time MDR applications to receive certificates compared to products that are transitioning from MDD.

Another major issue is that a significant number of applications are still being refused.

On the IVDR side, there has been notable progress on this front. In March 2023, 49 applications were refused, while another 16 were refused in June 2023. Only seven applications were refused in June 2024. While the survey only says half the applications were refused for “other” reasons, the other half were due to the wrong qualification of the product and one product was refused because the application was not complete.

The figures are larger on the MDR side. While the NBs received 26,185 MDR applications by June 2024, they also issued refusals to 620 applications. The survey found that 55% of MDR applications refusals were because the product was outside the NB’s scope and 16% were because the application was not complete.

“One key area to tackle is that NBs are still seeing significant problems with the quality of documentation that is being submitted, and this is evidenced by the data that show that nearly half of NBs see fewer than 25% of submissions that are deemed to be complete – i.e. the NB has to ask the manufacturer to submit additional information in over 75% of applications,” said Tunbridge. “This causes delays in starting conformity assessment work and will often indicate that there will be further delays during the conformity assessment process.”

“NBs are putting out a wide range of information to support manufacturers and I hope that increased support by EU authorities for NBs to have structured dialogue with manufacturers prior to the conformity assessment process will help to make a difference,” he added.

While there has been progress in transitioning to MDR and IVDR, there are still serious concerns whether there is enough time for manufacturers to meet their regulatory timelines. In response to these concerns, the European Parliament recently adopted a resolution acknowledging the need to update MDR and IVDR and avoid potential product shortages in the region. (RELATED: EU Parliament passes resolution citing ‘urgent need’ for MDR/IVDR revision, Regulatory Focus 28 October 2024)

Tunbridge, however, argued that the medtech sector has hit a tipping point where stakeholders across the EU regulatory system have some to grips with how the transition is happening and the immediate focus should be on how to implement the regulations rather than revising the underlying legislation. During the recent Medtech Conference in Toronto, he argued that while there still were some pinch points, there’s no need at this stage for an overhaul of the laws. He echoed those sentiments in his statements to Focus. (RELATED: Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR, Regulatory Focus 23 October 2024)

“We know that there are a number of areas of concern that we can address through pragmatic interpretation of the existing legislation and the associated revision of onerous guidance,” said Tunbridge. “At the same time there are some elements of the legislation that are key to driving harmonization, consistency and efficiency that have barely been used – common specifications and Eudamed are two very good examples.”

Similarly, Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD, told Focus that the resolution highlights the progress NBs have made.

“The Resolution of the EU Parliament of 23 October, which encourages EU Commission to come up with legal measures to improve MDR and IVDR as soon as possible, underlines the fact that improvements in MDR and IVDR are possible,” said Hoekstra-van den Bosch. “But the voices that warn not to change the legal system too hastily, and only based on solid data collection, have a point.”

With 50 notified bodies now designated for MDR, Hoekstra-van den Bosch said stakeholders feel there is sufficient capacity to handle the workload. While there are some specialized areas where there is a scarcity of expertise that may cause longer waiting times, the overall sense she said is that the NBs have enough resources to do their job.

Similarly, Hoekstra-van den Bosch said that the IVDR extension under Regulation 2024/1860 will be effective in giving the 13 IVDR NBs the time they need and developments around EU Reference Labs are encouraging in getting class D IVDs certified.

“Overall, the notified bodies (including my ‘own’ notified body TÜV SÜD, but not limited to TÜV SÜD) see that we get less submissions in than expected and planned for,” said Hoekstra-van den Bosch. “Notified bodies cannot escape the perception, that some manufacturers will be waiting until the end of the ‘extra time’ they have been given by Regulation 2023/607 to hand over their technical files for assessment by the notified bodies.”

“The fear is, that this will result again in longs queues towards the end of the extra time periods,” she added. “That is why you hear notified bodies say in public, at conferences etc. that it is key to submit technical files as soon as possible, so that the work can be planned appropriately, resulting in timely certification.”

Hoekstra-van den Bosch noted that there are areas that stakeholders may look at to propose improvements in the short-term.

“One of the issues is that there is a lack of clear and binding interpretation of the legal requirements, e.g. in the areas of classification, application of MDR article 61.10 (exception for clinical data requirements) and criteria for well-established technologies,” she said. “The vast amount of available guidance has not solved this. MDR/IVDR includes several legal instruments (delegated and implementing acts) that could provide such legally binding and harmonized interpretation.

“Also, the already available instrument of Common Specifications could be used to clarify and harmonize the expectations how to fulfil the clinical data requirements,” she added. “The Resolution of the EU Parliament of 23 October asks for proposals for such measures before the end of Q1 2025.”

“One of the main criticisms of the perceived over-regulation of the current legislative framework is that it was a knee-jerk reaction to scandals involving medical devices; we should avoid making the same mistake again,” Tunbridge added.

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.

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Experts: Notified body survey shows MDR/IVDR progress despite some snags

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