As Europe moves into the summer…

Gert W. Bos, PhD, Fraps "I have a deep interest in the industry and a desire to make a difference in patient's lives by improving patient care. Even those who don't work directly with patients can still significantly impact patient care by developing safer devices and systems for the future. Safety measures and clinical performance should be equally strong and valid in all cases."

This week, parts of Europe experienced the first warm and sunny days of the year, following an exceptionally wet and rainy period. Let's hope the same positive transition is ahead of us in the medical device and IVD regulatory space!

As Europe moves into the (probably) final stages of transition from the old directives into the new regulation, we have seen large numbers of manufacturers apply for the review towards conformity assessment in time to be able to utilize the full transition period whilst the review of their dossiers is ongoing. Yet we see medical doctors and hospital incoop…. Europe is starting to feel the impact of specific products being removed from manufacturers' offerings as they move into compliance with the MDR and IVDR. This is a logical response to the increased and detailed requirements, as well as the time, money, and resources needed for each dossier to comply with the new regulations.

Additional testing, clinical and performance evaluation, and generally updating and revising all documents is quite an effort. So, in many cases, only the latest versions and the most commonly used sizes of products are moving forward. However, this distinction is heavily influenced by the absence of size- and version-specific clinical/performance data. As such, the guidance on what constitutes sufficient clinical evidence for various products, sizes, and models has been highly anticipated but remains underdeveloped.

As a result, we now see stakeholders asking for improvements in the system, as the availability of specialty sizes and products is becoming challenging. We also see a push for special rules and mechanisms to foster innovative products and help SMEs maneuver the system with reasonable costs and timelines. Additionally, there is concern for pediatric patients, geriatric patients, and products needed for diseases not used in large quantities, tentatively referred to as 'orphan devices.

The frequency of finalized and published guidance appears to be slowing down, which is understandable given the focus on system mechanisms. At this stage, we understand the system's operations well enough. The next level of guidance should ideally help us navigate content-driven decision-making, determining what is good, acceptable, or insufficient, and what level of evidence is needed to support safe and effective devices. Some of this guidance may come from the expert panels' inner workings, but with the current volume of files being reviewed, it will take substantial time to develop product or category-specific guidance.

Hence the renewed call to action. First up was the German association BV-Med, coming up with a detailed position paper addressing these and other issues, with potential directions that (partial) solutions could take. This was soon followed by a whitepaper from the European MedTech association, and more visions for the future are being shared publicly.

Key is, however, to get the discussion into the space for legislative debate and reform, and informally that step was initiated by Dr. Peter Liese, a well know member of the European Parliament, previously also heavily involved in the development of the current legal framework for devices and IVDs. He came with a list of talking points on further improving the system, implementing improvements towards innovation and orphan devices (i.e. fast track procedures and binding guidance in structured dialogues and expect panel scientific advice)), SME’s (e.g. SME specific fees), and a general oversight and coordination from a new to be established organization called “The Office”. The office would include an ombudsman, classification dispute mechanism, and much more.

The idea for this office is inspired by the European AI Act, which is going live at this moment. With the structures and contents of the EU MDR, EU IVDR, and the AI Act not fully aligned, both offices together could potentially resolve many uncertainties in situations where both device/IVD and AI legislations apply.

These are exciting times ahead, where, with good debates and improvements, Europe can move forward into the bright light of summer. A fast-track route to clarity in the regulatory space will help us get back on track with innovation, enhance SMEs' abilities to work within the system, and ensure we continue to provide care for all patients—young and old, big and small, with general or specific diseases. Ensuring the availability of all necessary medical devices, rather than just a selection of essentials, is paramount.

Let the summer begin!



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