IVDR implementation day overshadowed by lack of notified bodies, risks to patients

While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle the influx of conformity assessments necessitated by the new regulation.
 
On 26 May, medtech manufacturers, notified bodies and regulators woke up to a brave new world where IVDR is the law of the land. Under the regulation, new diagnostic devices, legacy devices and existing devices will be regulated under a framework that EU regulators assert is fairer, more streamlined and better for patients.
 
“The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in medical science,” said the European Commission. “By aligning market access requirements in the different EU Member States, it also safeguards fair market access for manufacturers.”
 
But that’s easier said than done, according to industry experts who have been tracking the issue for years.
 
“The transition into the new EU IVDR will likely not run smooth for manufacturers and regulators, and also hospitals and other caregivers will notice hiccups in supply,” said Gert Bos, executive director of the Qserve Group and president of the Regulatory Affairs Professionals Society’s (RAPS) board of directors.
 
“We will also experience that, without warning, some products will cease to be available in the market,” he warned.
 
Bos noted that the notified bodies recently published findings of an annual survey looking at their available resources and the percentage of IVDs that have already transitioned to the new regulations, and the numbers don’t look good. He said that based on the survey, it is clear that only a small percentage of IVDs will make it through the transition window as the new regulations go into effect.
 
One of the biggest concerns has been that there won’t be enough notified bodies to handle the caseload of IVDs that need to be certified under the new regulations. While it is a big concern, Bos said the root cause of the problem isn’t the lack of notified bodies.
 
“If all notified bodies would have been designated years ago, they might have had a fighting chance to be able to cover the workload by adding huge resources; something you can only do and invest in if you have the outlook that you will be designated shortly,” said Gert. “But more would have been better, and unfortunately the lengthy process has led early new start-up notified bodies in IVDR field to abandon the process as continued investments were unacceptable for the companies interested.”
 
“Getting additional notified bodies in only is feasible if we find a system that allow them to have their staff do paid work instead of sitting idle on the bench for 800 days (which is the average of the current designation timeline),” he added. “Solutions will need to be sought in changing the process, extending the timelines, or keeping current products on the market for a longer period using a creative scheme.”
 
Erik Vollebregt, a partner at Axon Lawyers, published an extensive blog on how the new regulations will be transitioned and what they mean for various stakeholders. He too said the lack of notified bodies is the elephant in the room.
 
“Whenever there is something to celebrate on a party there is also an elephant in the room, like an uncle that always gets just a little too drunk and ruins the party for everyone,” he wrote. “In this case it is the notified body capacity elephant, which stands to put a serious dent in the IVDR project, regardless of the measures taken with the recent [January 2022] amendment.”
 
Vollebregt noted that IVD manufacturers have not started applying for certification en masse and the sector is making the same mistakes device-makers did when the EU Medical Device Regulation (MDR) fully went into effect last year. He acknowledged that the low number of applications to notified bodies may also be due to the low number of notified bodies that have become operational.
 
Vollebregt added that another worrying development is that at least half of the submissions to notified bodies are incomplete which raises the possibility that either notified bodies are not adequately explaining to IVD manufacturers what they need, or the manufacturers are not good at completing their applications. Either way, there seems to be some misunderstandings between the sides.
 
“Regardless of the recent change to the IVDR, the IVDR will be in the same boat by 26 May 2025, when the first grace period under the IVDR expires,” Vollebregt warned. “With the number of notified bodies notified for the IVDR, and the speed at which this happens, I predict the exact same issues with the IVDR.”
 
MedTech Europe, the European medtech lobby group, has previously said there needs to be almost eight times the number of notified bodies as there is now to handle applications when the IVDR goes into effect. In a statement, the group warned that lack of capacity poses a significant number of risks to patients and the European medtech ecosystem, and urged regulators to “urgently designate and build considerably more Notified Body capacity to support certification of all IVDs and reduce the long and unpredictable certification timelines we have today.”
“Until these challenges are resolved, the IVD Regulation will not constitute a sufficiently predictable and reliable pathway to certification of needed medical tests,” the group added. “Such challenges need ongoing attention and work by the EU Commission and Medical Devices Coordination Group, if Europe is to ensure a workable system both today and over the longer term.”
 
Looking more specifically into the regulations, Bos said the most critical issue that still needs to be addressed is what constitutes success. He said there needs to be clarity on what is considered good enough in terms of pre-market validation, including clinical and performance testing.
 
But ultimately, he said this is a shared effort and all sides need to go easy on each other.
 
“Be kind to each other in the interest of patients,” he said. “If a file is close to what we expect, issue the certificate and fix the final details in the years to come under supervision of the notified bodies. Focus on what is right, not on what is wrong or missing!”
 
“We cannot afford to have a massive stand-still in hospitals in Europe because some essential tests are missing,” he added. “The last two years have shown the trouble to society when hospitals are not fully open, and it would be a shame on all if for regulatory reason, instead of a heavy pandemic, we would cause serious disruption in healthcare again.”