Euro Convergence: Experts share advice, concerns and expectations for IVDR

Regulatory NewsRegulatory News | 03 November 2020 |  By 

In a panel at RAPS’ Euro Convergence, top experts on the EU In Vitro Diagnostic Regulation (IVDR) discussed the state of the industry just 18 months before the regulation’s May 2022 date of application.
Opening the session, Gert Bos, executive director and partner at Qserve Group, laid out the stakes for IVD developers: “Yes, IVRD is different from [the Medical Device Regulation] MDR, the pressure is much higher because there is such a big gap between the current situation, the current legislation and the future legislation. The grace period is nice, but for the majority of the products it is not applicable and as such we will all see the crunch, the pressure, the pain in the next year and a half, but hopefully in a shorter time we have solutions,” Bos said.
Armin Ritzhaupt, scientific administrator at the European Medicines Agency (EMA), discussed some of the unique challenges surrounding companion diagnostics under the regulation and said the lack of guidance in some areas has been a hindrance.
“Who would have thought that three or more years after the adoption we are still talking about where is the guidance, where are some of the other elements we would like to see? And yes, we have been working on them, perhaps with some interruptions,” he said, pointing to Brexit and the COVID-19 pandemic as major disruptions impacting the runup to the regulation.
Tom Patten, certification and inspection officer at the National Standards Authority of Ireland (NSAI), addressed the gap between notified body designed under IVDR compared to the MDR.
“Under the IVDR, you’re more than likely to need a notified body than to not need a notified body,” Patten said. Patten said that most IVDs, aside from non-sterile Class A devices, will need a notified body to certify them.
Patten urged IVD makers that will require a notified body to engage with one as soon as possible and compelled them to use the Medical Device Coordination Group guidance on IVD classification once it is made available later this year.
Andreas Stange, vice president at TÜV SÜD Japan, shared some of his concerns. “The low number of designated notified bodies to date is also a headache for us because we can’t do everything on our own,” he said, echoing Ritzhaupt’s sentiment on the missing guidances.
Stange stressed the importance of manufacturers having high-quality technical files to support their IVDs. “We see unfortunately that quite a big part of technical files are of very poor quality … We can’t repeat ourselves often enough, please listen and look at that, because you save yourself a lot of time and money.”
Sue Spencer, IVD lead/principal consultant at Qserve Group, agreed that many submissions she has seen are of poor quality and instructed IVD makers to “read and understand the requirements extremely specifically. You can’t assume that the notified body is going to join the dots together between the two because they are not allowed to do so.”
Stange also bemoaned the inability of notified bodies to certify products without conducting onsite audits, something that has proved to be a significant challenge during the COVID-19 pandemic.
Simon Richards, vice president, divisional regulatory affairs at Abbott Rapid Diagnostics, said that IVD makers must take the challenges in stride and not assume that things will get easier. “We have real challenges from a business point of view, but that doesn’t mean that we should assume that those challenges are going to get any easier. There is always change in business and we need to really get out there and get the activities going,” he said.
When asked how many notified bodies he expects to come online before the date of application, Patten said, “I don’t even begin to know how to work that out,” adding that that he would like to see all the notified bodies that have applied become designated.
Patten acknowledged that getting more notified bodies designated is a challenge under the current circumstances. “Notified bodies cannot go on-site at the moment, joint assessments to designate notified bodies also can’t take place, so perhaps in a different year we would have more notified bodies over the line.”
But he said, “By May of next year I would say there will hopefully be a lot more over the line.” Patten said he believes another notified body will be designated soon, with two more will likely follow shortly.
Some of the panelists discussed the flexibility to use data from other sources, such as 510(k) submissions to the US Food and Drug Administration (FDA) to support their certification under IVDR.
“If it’s an old 510(k), reproducibility wasn’t always expected by FDA back in the day, but it is a requirement under the IVDR,” Spencer said. “You have to make sure it’s clear why it’s relevant to the submission you’re making.”
Richards agreed, saying that it does not matter whether data comes from a 510(k) or another type of submission, but whether a manufacturer can justify the use of the data for their product and its intended purpose. “It really just comes back to can you justify it in terms of the criteria you’re using under IVDR,” he said.
Panelists were asked whether they think the date of application for IVDR would be delayed as it was for the MDR.
Patten said he does not believe a delay is necessary as long as all the major components are in place before the date of application. “Notified bodies support the current date of application as long as the tools that were agreed on to support the regulation, common specifications, EU reference labs, expert panels, as long as they’re in place we do support the current date of application,” he said.
Spencer said, “It would be nice to have an extension, but I wouldn’t put a huge amount of money on it.”
Stange chimed in that any shift in the date of application should be announced well beforehand. “This was very challenging for us, the MDR shift, if any [IVDR] shift is done, it should be planned in a proper way and announced not on such short notice,” he said.
Richards concurred that companies should not rely on a delay but said it would be possible for the European Commission to delay or provide flexibility for some of the more challenging aspects of IVDR.
“There is a possibility that the time would stay the same, but there may be other changes that the commission could do, so for instance it may well decide that all class D devices without [common specifications] would not need to go through reference labs,” Richards said.

Euro Convergence


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