Regarding the EU Commission's selective MDR/IVDR amendment proposals of 9 December 2022
- Swiss Medtech is pleased that problems with MDR implementation and the associated negative consequences on patient care are now being addressed by the EU. It is a clear admission that the system is not fit for purpose. The medtech industry - in Switzerland and across Europe - has been issuing warnings for years. Increasingly, joined by various other health stakeholders. The window for action is almost closed. The only option left is damage control.
- The EU Commission's decision to quickly amend the MDR selectively to allow the conversion of existing products (MDD products) into MDR products is sensible. This will somewhat defuse the impending supply problem with a view to 26 May 2024. However, the long-term supply of medical devices for the population is not at all guaranteed. Sustainable provision must ensure the availability, range, and quality of existing and new medical products.
- The EU is attempting to put out the flames. The MDR system, however, still contains fundamental weaknesses which cannot be eliminated with the intended selective changes. The regulations must be fundamentally revised. The EU does not want to undertake this conceptual until it has completed a review in 2027, as required by EU law. This, despite the fact that structural problems are already acknowledged today, and that the Notified Bodies system is not functioning.
- The consequences are already evident today. The USA has overtaken the EU when it comes to initial approvals of medical devices. Increasingly, companies in Europe and Switzerland are prioritising FDA approval over CE-certification. This shift is largely due to the (legal) uncertainties associated with the MDR and the excessive increase in requirements. In addition, the FDA has made significant efforts to incorporate digital trends and technological advances into its regulatory framework.
- History speaks for itself: In 2017, the MDR came into force with a start date of May 2020. Then in April 2020, the start date was postponed by one year to May 2021 with a transition period until May 2024. And now the transition periods have been postponed to May 2027 and May 2028. The EU will have to conduct an evaluation in 2027 and then, if necessary, tackle a fundamental revision. Considering it took ten years to draft the MDR, a conceptual revision is likely to require at least another four.
- Of course, a functioning MDR system is still of central importance for Switzerland - as a country in the middle of Europe, and with the EU as its most important trading partner. However, in view of the problems, relying solely on the poorly functioning EU system would be irresponsible.
- Switzerland should feel justified in its intention to recognise not only CE-marked medical products, but also those with FDA approval. At the end of November 2022, the Swiss parliament gave the Federal Council a mandate to this effect. It was a far-sighted political decision. Given the timeframes and uncertainties surrounding the fundamental MDR revision, a swift and rapid implementation of the Motion 20.3211 by Councillor of States Damian Müller «For more room for manoeuvre in the procurement of medical devices for the care of the Swiss population» is all the more important. Europe has manoeuvred itself into a situation with the MDR that is detrimental to the medical technology industry, patient care, and Europe as a location for innovation. For Switzerland, implementing the motion could provide a way out of this difficult situation.
- The Federal Council has two years to implement the Müller motion. Much too late! - many say. When discussing timeframes, we must keep the MDR in mind for comparison. On the one hand, we have a tried and tested functioning FDA system with a central state licensing authority and, on the other hand, an MDR system that is demonstrably not (yet) fit for purpose and, according to experts, will only be ready in ten years at the earliest.