- A director at MedTech Europe warned the AdvaMed conference this week that the European Union will experience a turbulent transition to the In Vitro Diagnostic Regulation.
- Oliver Bisazza, director, regulations and industrial policy at the trade group, said that the current rate of progress will unfortunately see the EU "needlessly lose a great deal of tests." However, after repeatedly sounding the alarm, Bisazza said he is nonetheless confident decision makers will "course correct" ultimately.
- Bisazza made the comments at a MedTech Conference session on Tuesday discussing whether the systems for IVDR and the Medical Device Regulation are now ready. While the panelists highlighted ongoing areas of concern regarding MDR, they voiced their strongest worries about IVDR.
Bisazza was joined by five other people at a session of the MedTech Conference to discuss MDR and IVDR. Asked whether the systems are finally ready, Bisazza used a shipping metaphor to explain the state of play. MDR has set sail but needs work to ensure it stays afloat. IVDR, in Bisazza's view, is in a more perilous position.
"It seems clear that with the current timelines and the current rate of progress, Europe's on track to, I would say, needlessly lose a great deal of tests. But it's not too late to reverse that trend. We think it can be avoided," Bisazza said.
MedTech Europe has been making similar statements, supported by surveys of its members and data on notified bodies, for many months. Outwardly, there has been little evidence that the messaging is driving action among the people who are in a position to avert the crisis that MedTech Europe believes the EU is heading toward. That might be about to change, though.
"We know the challenges of making the IVD regulation work on time are widely acknowledged ... by the European institutions," Bisazza said. "Without having the crystal ball for what's going to be done about that next, we are confident that soon, hopefully, the decision makers will take action to course correct this so that the IVDR ship will be ready to sail in a smooth manner."
MedTech Europe has previously warned that between 24% and 61% of IVDs will be certified by the IVDR date of application in May. The trade group expects at least 22% of currently marketed IVDs to be discontinued. The EU previously delayed the MDR date of application in the face of dire warnings about its impact on medical devices, but that action was in part because of the disruption at the height of the pandemic.
The panelists discussed how the EU may cope with the removal of a significant number of IVDs from the market. Erik Vollebregt, a partner at Axon Lawyers who specializes in medical devices, suggested that in his own country of the Netherlands hospitals could "pick up the slack" as they already make many tests themselves.
Bernhard Bichsel, senior consultant at medtech service provider ISS AG, agreed that hospitals could make up for the removal of IVDs from the market, while also pointing out some downsides of relying on them to mitigate the impact of the regulations.
"If you give it to more, let's say, off-label and in-house elements, which are controlled less than the products on the market, it's a bit of a trade off. But in terms of shortages, I would agree they could maybe bridge the gap," Bichsel said.