Effective medical technology governance sits at the core of Europe’s health systems, shaping patient access, regulatory efficiency, and industry competitiveness. In this Directors Digest, I reflect on the complex regulatory landscape with multiple layers and rising stakeholder expectations. In this context, governance reform is more than a policy ambition; it is a necessity to maintain Europe’s leadership in medical technology. Here I comment on the current framework and highlight the need for change, perhaps with a centralised model that can propel the sector forward.

Background and Context

Europe’s medical technology market is both substantial and dynamic, representing thousands of manufacturers, from multinational corporations to innovative SMEs. However, with the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the sector now contends with pronounced regulatory challenges. Some of these include:

• multiple authorities with overlapping responsibilities resulting in inefficiencies and uncertainty;

• no single body ensures timely, safe access to devices; and

• administrative redundancy and unpredictable pathways increase expenditures for manufacturers and health systems.

In 2023, industry stakeholders highlighted these systemic issues in a joint discussion paper, calling for urgent restructuring to secure Europe’s health technology future (see links provided below).

Analysis and Insights

Current System: Challenges and Statistics

Today’s decentralised regulatory model involves the European Commission, Medical Devices Coordination Group, national authorities, Notified Bodies, and expert panels—each with varied mandates. This multi-agency structure has contributed to considerable delay. Picture the challenge for innovative medical devices entering the market, particularly among smaller companies. Reports indicate that the average approval time for new devices has increased by over 30% under MDR, with some products taking up to 18 months to reach the market. There is a cost and risk for putting capital to work in such lengthy approval times.

Why Centralisation Matters

A proposed solution is a centralised structure to standardise procedures, reduce bureaucracy, and establish clear performance metrics, minimising delays and unpredictability in the regulatory process. One empowered institution would drive system-wide decisions, monitor market performance, and coordinate international alignment. Unified oversight from a central structure could streamline conformity assessments and support timely device certification, benefiting both patients and manufacturers.

The key functions of a new central structure would include strategic oversight of the MDR and IVDR systems, with authority to adapt quickly to market developments and public health challenges. It would also use key performance indicators for consistency and speed across all Notified Bodies. The central structure would also enable a coordinated approach to horizontal EU legislation (such as digital and environmental policies), reducing conflicting requirements and enabling sustainable innovation. Finally, with additional resources, it could meaningfully engage all stakeholders—industry, patients, regulators—at every major decision point.

Implications and Recommendations

For policy-makers, the case for reforming medical technology governance is clear. Europe may need a central structure with the mandate, resources, and expertise to navigate a rapidly changing landscape. Direct benefits include reduced redundancies, improved regulatory timelines, and increased market attractiveness for local and international innovators. For market access leaders, these reforms offer greater predictability for launch planning and health technology assessment, smoothing commercialisation and reimbursement pathways for new devices.

Health system leaders stand to gain through enhanced resilience, faster patient access to breakthrough diagnostics and treatments, and optimised resource allocation in times of crisis. This would include pursuing swift legislative action to define levels of accountability and making responsibilities transparent. Also, it could benefit from embedding standard operating procedures, digital tools, and performance monitoring in the regulation process to minimise delays and costs. It would also be beneficial to promote earlier and broader stakeholder engagement to test policy proposals and assess real-world impact before implementation.

However, a centralised governance structure could lead to a one-size-fits-all approach that fails to accommodate the diverse needs of different Member States. This could potentially stifle regional innovation and responsiveness to local health challenges. The concentration of power in a single entity could result in bureaucratic bottlenecks, where decision-making becomes slower and less adaptable to rapid technological advancements or urgent public health needs. The establishment of such a structure could also incur significant costs and require substantial resources, which might divert funding from other critical areas of healthcare and innovation.

Conclusion

Europe’s future in medical technology depends on the integrity and agility of its governance systems. By advancing medical technology governance reform, policymakers and industry alike can transform current challenges into opportunities—delivering better access, safer devices, and robust innovation capacity.

Sources