Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell, examines proposed changes and how they could be improved

As vital tools for treating sickness, preventing health problems, and saving lives, medical devices and in vitro diagnostic medical devices (IVDs) must of course comply with stringent, comprehensive safety and performance requirements.

With the MedTech landscape constantly shifting, those requirements must also allow space for an effective flow of innovation in order to facilitate timely delivery of advanced tools.

Almost 10 years ago, Europe’s regulatory framework for medical technologies, the Medical Device (MDR) and In Vitro Diagnostics Regulations (IVDR), were inaugurated with the intention of providing a robust, modern, unified system, which ensured high standards of safety and performance.

It is now, however, widely recognised that the existing framework is at a decisive moment. Fundamentally, the regulations as they stand are failing to fully meet original objectives with backlogs caused by a shortage of notified bodies certified to review and approve a massive influx of complex device applications.

Makers of medical products placed on the EU market have become mired in slow conformity assessment timelines, unpredictable delays, high compliance costs, and inconsistent interpretation across different EU countries.

In turn, these issues with the existing framework are affecting patient access to technologies, the availability of some devices and diagnostics, not to mention Europe’s prospects as an attractive place for MedTech investment.

Revision is required then to place the primary focus back on meeting patients’ needs — and the European Commission’s ambition of achieving that is well underway.

Regulators have noted the issues, understood the challenges, and analysed how the system could work more efficiently without compromising safety.

It has led to proposed measures for simplification and streamlining, improved predictability, encouragement of earlier regulatory dialogue and better international cooperation.

Collectively, they are expected to bring urgently needed improvements to Europe’s MedTech sector for the benefit of both patients while planting the seeds of economic growth opportunities.

Essentially, the foundation for reform, based firmly on reduced complexity and enhanced focus on identifying risk, is evident.

In particular, positive proposals include scrapping the rigid five-year re-certification cycle for device conformity, replacing it instead with continuous surveillance models to cut down administrative burden.

There is further streamlining in the case of a proposed clearer distinction for post-certification product changes to reduce administrative bottlenecks.

The proposals also mark improved innovation pathways with the introduction of regulatory sandboxes and early scientific advice for breakthrough and AI technologies, while implementation of the new EUDAMED medical device database means far greater transparency including full traceability of medical devices and post-market surveillance data.

Nevertheless, there are areas of concern. Fundamentally, time is now of the essence for these proposals amid many existing challenges such as blockages to device availability for Europe’s patients.

How quickly then can change be successfully implemented, particularly in ensuring that assessment pathways can become efficient and reliable, in turn bringing investors to Europe? Revision must therefore be urgently yet rigorously undertaken.

The proposals also currently mean that devices will be presumed reusable unless manufacturers justify a single-use designation. This departure from the current MDR framework should be reevaluated with consideration given to removing the onus on manufacturers to justify that devices which are single use only cannot be reused.

Balancing speed of implementation with safety and adaptability will be the true mark of success for these proposals, placing patients first, getting products into their hands faster, while helping to ensure Europe’s long-term competitiveness.