Oliver Bisazza: The workability of the transition period is our biggest concern. The regulatory system is being built as the transition period kicks in, and it continues to be built. It is far from being as ready as we ideally need it to be by now. But our members need to make use of the system already, since the MDR fully applies in just 12 months, i.e. from 26 May 2020, and the IVDR, with its broadly-increased demands on industry, 26 May 2022. We believe we are heading for serious problems and potentially a crisis in patient care – unless something changes or there is action from the Commission and contingencies are put in place. We have 12 months left on the devices side. Industry has been working very hard for the last two years to get ready, but can’t submit its technical files to the notified bodies: we only have one notified body so far and that is one based in the UK which intends to leave the EU. So this means the industry has no one else to whom it can submit files. Companies will have fewer than 12 months to do all their product recertification. This is a problem for industry, the health-care system and for patients. All the EU national authorities know very well that this is the situation we are in, but no one wants to be the authority that first publicly admits it. The EU is insisting at the level of the European Parliament, on the record, that all is going to plan. This is giving us increasing concern, because it seems really clear that the three- to five-year transition period is not available to us, as it needed to be; it is being used up by the authorities to build the regulatory system, leaving too little time for products to get approved. When our members hear claims from the Commission that everything is going well, it causes great concern, as this is completely at odds with their own experiences on the ground. Our fear is that there is a real risk that the new regulatory system could fail unless something is corrected. We need the EU contingencies to be developed, and communicated, that are sufficiently robust and dependable, so manufacturers know that, if their products are not able to be approved in time despite their best efforts, they won’t be left to run into a wall and that they will be taken care of. That’s what is needed more than anything else right now to maintain business confidence and keep people committed to Europe. On the IVDR side, there has been a recent slowdown in the implementation of the IVDR. It could be linked to the fact that, as the final 12-month run-down to the full MDR implementation is nearly upon us, everyone is starting to really focus on the MDR, and so there has been a noticeable slowdown on the authorities’ side in the implementation of the IVDR. IVDs have more time, but we need to see an ambitious level of momentum maintained on that front too, to avoid a bigger problem with IVDs in just a couple of years’ time.

Heading For Crisis: The Upturn In EU Medtech Regulatory Output Is ‘Not Enough’ – MedTech Europe

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