The EU Medical Device Regulation: How to Improve MDR for Better Access and Innovation?

The evaluation of the EU Medical Device Regulation (MDR) is ongoing: what’s not working, and how can we improve it?

At SDA Bocconi, we invited Flora Giorgio (DG SANTE, European Commission) together with regulators, industry leaders, and academics for a Privileged Talk to discuss the key challenges and potential solutions for medical device market access in Europe.

Flora Giorgio outlined the Commission’s priorities: actions to improve predictability and reduce burdens. While MDR was designed to ensure patient safety and strengthen the Single Market, its implementation has revealed challenges that need to be fixed without compromising the core objectives of the MDR. Improvements can already be made now, through targeted actions, and the ongoing evaluation will inform the next steps.

Andrea Rappagliosi, MedTech Europe raised the issue of the length and complexity of approval processes, which risk delaying access to innovative, implantable, medical technologies. While other jurisdictions have introduced accelerated pathways for breakthrough devices, Europe has yet to do so, making it less competitive compared to other regions. At the same time, low harmonisation in the implementation of the MDR by the different player, creates inconsistencies and inefficiencies, making compliance more challenging for manufacturers (Loris Chiusoli, TUV SUD).

Another critical point was the low quality and quantity of clinical evidence supporting medical device approvals. This raises concerns about whether the available data is robust enough to support market entry and long-term safety assessments (Alan Fraser, CORE MD). Strengthening post-market surveillance and integrating structured data collection could improve regulatory predictability while maintaining high safety standards (Philip Collis, Patients Research Partner).

A promising direction is the adoption of a lifecycle approach, where regulatory requirements evolve alongside the technology rather than being rigidly divided into pre- and post-market phases. A major step in this direction is the EU-funded project coordinated by Bocconi University, which is developing an Early Feasibility Studies (EFS) framework for Europe. Similar to the established EFS program in the United States, this initiative aims to create structured mechanisms for generating clinical evidence earlier in the process, providing a more predictable and efficient pathway for high-risk medical devices (Giuditta Callea, SDA Bocconi).

Another key aspect discussed was the role of Health Technology Assessment (HTAR) in improving market access. While the Joint Clinical Assessment (JCA) under HTAR aims to streamline evaluations across Member States, its integration with MDR remains complex. Ensuring a coordinated and predictable process will be crucial to reducing delays and uncertainty for manufacturers and healthcare providers (Marco Marchetti, AGENAS).

Building on this, the discussion explored the need for an Accelerated Patients’ Access Program—a structured model that would integrate regulatory approval with post-market assessment to streamline market entry while ensuring continuous data collection. The ongoing work of the MDCG on breakthrough technologies could provide a foundation for such an approach, (Rosanna Tarricone, SDA Bocconi).

The key takeaway? The implementation of the MDR, as it stands today, presents challenges that must be addressed. All key players working together can already improve the system today. The upcoming review period is a crucial opportunity to make the system more efficient, predictable, and innovation-friendly—while upholding the highest safety standards.

A big thank you to Flora Giorgio, Andrea Rappagliosi, Loris Chiusoli, Marco Marchetti, Alan Fraser, Philip Collis, Giuditta Callea, and Rosanna Tarricone for their invaluable insights.

Let’s work together to ensure that Europe remains at the forefront of medical innovation.