Nine months out from the new start date of the EU Medical Device Regulation, the medtech industry is still largely in the thick of responding to COVID-19.
While many in the sector long pushed vehemently for a delay, which ultimately came in light of the pandemic, some players that were better prepared felt the pinch of switching gears with the 11th hour decision to move the original May 2020 date of application by one year.
After COVID-19 took hold, industry association MedTech Europe proposed a similar delay to implementation of the In Vitro Diagnostic Regulation (IVDR), and also pushed for notified bodies to be allowed to conduct virtual audits during the pandemic. Neither changes have come to fruition, as of yet.
MedTech Dive recently caught up with MedTech Europe regulatory lead Oliver Bisazza, who shared the organization's current thinking on IVDR, virtual audits and more.
The following responses have been lightly edited for brevity and clarity.
What is currently MedTech Europe's biggest focus?
It has to be our association's number one focus to support the healthcare systems in managing this pandemic.
Alongside that, we still develop substantial energy and focus on our usual strategic priorities, and the regulatory agenda has always been towards the very top of that, because we are regulated by sectorial legislation, the MDR and IVDR, moving forward with those continues to be a very high priority for our industry. I would say at a high level, given where we are in the process, we are prioritizing IVDR even more these days ... I would really like to stress the growing importance of IVDR for our sector because it's often having to patiently wait for its turn while everyone focuses on MDR.
We're well into the second half of those regulations' transition periods ... We've always thought the transitional periods were extremely ambitious, ever since they were crafted. We've seen the EU struggle to quickly put in place all the regulatory infrastructure that needs to be built in order for us to comply as the regulated industry. A one-year postponement to the MDR earlier this year was a necessary [step] the EU took because of COVID-19 and because it gave them as the the authorities more time to get the system ready.
We're seeing that problem all over again with IVDR, potentially on a much bigger scale, and no solutions have been hashed out for that one just yet. So you start to see why it's becoming such a central cause of concern for our sector right now.
Shifting the focus to IVDR
Following the MDR delay, has the proposed IVDR delay gained any traction? What other solutions have been discussed?
While the political climate was such that there was an immediate 'yes' on the MDR side, we have had nothing but radio silence on the IVDR side. We haven't received a yes, we haven't received a no, there just seems to be still this inertia, this unwillingness, to talk about the IVDR as much as we think it should be. So, I have to say on the side of the lawmakers, be they the national governments or the European Commission, we're not getting any official answers yet on IVDR.
But we have seen more IVD stakeholders start to join in the conversation. It is not just us as industry expressing concerns ... I believe the time is right for other stakeholders to join in the conversation: be they the notified bodies, be they the hospitals, be they the authorized representatives. I think we need to have more of a public debate starting about the IVDR transition. And then the authorities can tell us exactly what it is they're prepared to do about it. But for right now, we are seeing more conversation with the stakeholders than we are with the actual lawmakers, unfortunately.
Have things played out as you expected during COVID-19 in terms of there being a slowdown in IVDR prep?
Absolutely. We have seen that, and we are still seeing that in the second half of the year.
Many manufacturers have been on the receiving end of unprecedented demand worldwide for COVID-19 tests, and it was our public health responsibility to prioritize help in the manufacturing and scaling up with those tests ... that has resulted in many people within companies dropping their day job to help in that effort.
We've also seen, unfortunately, the authorities have needed to do the same thing.
The people we work with in the European Commission, the national competent authorities, some of them have told me in private capacity, very explicitly, that implementing the regulations is a low priority right now; the priority is COVID and helping us get past this pandemic.
We've seen, for instance, one of the European committees, where all the different authorities come together to move forward with IVDR implementation (we participate there as stakeholders): when they met in May, IVDR was not even on the agenda, which was unheard of. Everything was COVID, COVID, COVID ... perfectly valid and admirable, but it shows painfully obviously how much implementation has slowed down and taken a backseat, which is exactly what we feared would happen and it highlights the fact that the transition is not in a good place.
Preparations for MDR
How has the medical device industry responded to that one-year delay?
First of all, we do believe that that delay needed to happen because the date of application was on track to happen right in the middle of Europe's peak of coronavirus cases, which was untenable. On the other hand, it's true that we were always calling the last three years for solutions to the transition — be it postponement, be it something else — for it to be done early and proactively because when these things happen really in the 11th hour, it can cause some disruption. Some companies who felt they were 100% MDR ready felt a bit shortchanged by this, as did some notified bodies who had pulled out all the stops to get ready and were ready to move to the new system.
Notified bodies have been instructed, really ordered, by the authorities to prioritize certain manufacturers and certain products over others. There was a clear directive that came down saying 'we're facing a worldwide shortage of things like face masks, ventilators, COVID-19 tests' — potentially wherever the notified body was involved in the assessment of those products, they were asked to push all those products to the front of the queue, which makes sense from a public health point of view, but it has resulted in some manufacturers being trumped by others.
Although the postponement gave an extra year, we've got notified bodies [and companies] who are ready to move forward with the new regime; they were ready to move forward with MDR and IVDR this year. They're not particularly eager to switch back for 12 more months to the old regime. They invested heavily to get ready. And they are feeling in some cases very frustrated that they can't proceed with the notified body audits ... The MDR and IVDR require that many notified body audits happen on site at the premises of the manufacturer. And that's still not possible in many parts of the world, such as many parts of the United States.
We have lots of cases, we're told, of manufacturers who had audits [scheduled for] March, April, May, June, July — and those audits have had to be canceled or postponed. And so that extra year has been given, but it has not really always been possible for everyone to move forward with the new regulatory system. And what we've been calling for is for Europe to do what some other sectors are doing which is allow these audits to take place virtually, you know, because we're in the time of virtual meetings virtual conferences. It's not clear when we can return to normal and people can physically visit the sites of manufacturers.
What are you seeing in terms of notified body capacity?
It improves every year of course, as the notified bodies staff up and as more notified bodies get designated. Again, the extra year of transition time for the MDR was important because it enabled the EU to designate a few more notified bodies.
'Is it enough?' is a very difficult question to answer ... the hope is that with this extra year we will no longer have a bottleneck for the renewals of the MDD certificates, meaning that it should be possible, I hope, for manufacturers to transition their files to MDR gradually between now and May 2024. There could very well be bottlenecks in May 2024, if the final amount of available notified bodies is not sufficient. But I would say it's a bit too early to judge that at this stage.
What's the deal with the virtual audits proposal?
Even if some decision-makers would like to allow virtual audits to happen, the regulations themselves are very black and white. They have legally binding language saying that certain types of audits like the initial certification audit needs to happen at the premises. Perhaps in some people's minds, you cannot just ignore this or address it purely through guidance; you might need to amend the regulations formally, you might need to actually once again reopen [it] and change what these bits say.
It would have been extraordinary for me to suggest something like that last year, but this year has shown just how quickly you can modify and legislate when there's political will ... The MDR postponement was the classic example; it took only something like four weeks from start to finish, which is extraordinarily quick ... normally it would have taken months and months. So I'm not saying the EU is necessarily going to do this every day, every time it has an issue. But it's shown that in times of exceptional need, which I think this is, there is the possibility to do it. It just requires a certain minimum threshold of political will to go there and actually change what the regulation says.