On 16 March, around 300 representatives of EU institutions, national authorities, notified bodies, industry and stakeholders took part in the European Commission Conference on the future of medical device and in vitro diagnostic regulation in the EU, held in Brussels under the aegis of the Presidency of the Council of the EU currently held by Cyprus.
During the Conference, the Commission presented the proposal to revise the regulations on medical devices and in vitro diagnostics (MDR and IVDR), offering an important opportunity for discussion on a regulatory framework that directly affects the lives of millions of European patients and the competitiveness of a strategic sector for the European economy.
Looking back, in 2017 a stricter regime was introduced to strengthen safety following a series of serious incidents. The objective was clear and widely shared: to improve the protection of patients / users. However, the difficult and slow implementation of the regulations has generated unintended consequences that now weigh on the entire ecosystem: excessive administrative burdens, inconsistent interpretations by notified bodies, shortages in regulatory capacity and concrete obstacles to innovation.
The result? Devices that do not reach the market or are withdrawn from the market, putting at risk the very care and safety of patients that the regulation was meant to protect, and a high risk that industry will turn to other continents to launch its products.
Health Commissioner Olivér Várhelyi clearly outlined the priorities of the proposed reform: ensure timely access to safe and effective devices, create a predictable regulatory environment for businesses, provide concrete support to SMEs and investors, and strengthen the EU’s strategic competitiveness. His appeal to the European Parliament and the Council was direct: act quickly, because national health systems are already facing the consequences of device shortages. The contribution of stakeholders will be essential to define effective rules, consistently linked to patient safety.
During the conference, the economic and social weight of the sector emerged strongly: medical technologies are worth 170 billion euros (2024 data) and employ more than 900,000 people in over 38,000 companies, 90% of which are SMEs. These are not just numbers, but productive capacity, innovation and employment spread across the whole European territory. Protecting this ecosystem also means safeguarding Europe’s technological sovereignty in a critical sector.
One of the most important messages to emerge from the debate is that safety and innovation are not conflicting goals, but must go hand in hand. Regulatory clarity and consistency are needed across the various interconnected regulatory frameworks, including the AI Act. Accelerated pathways are needed for innovative and orphan devices. And above all, patients must be placed at the centre: their involvement must be meaningful at every stage of the regulatory process, not merely formal.
The European Commission has already prepared urgent measures: it has proposed implementing and delegated acts on fixed timelines for conformity assessment and the extension of the lists of “legacy” devices, whose adoption is expected shortly. The long-term reforms propose simplification that maintains high safety standards through risk-based approaches, eliminating duplication and supporting innovation through dedicated pathways for innovative devices, regulatory sandboxes and integration of artificial intelligence. These initiatives fit into a broader framework of EU health reforms, including the revision of pharmaceutical legislation, the Biotech Act and the Safe Hearts Plan.
The Cypriot Minister of Health, Neophytos Charalambides, also stressed the urgent need to modernise and recalibrate the regulatory framework. This is essential to maintain Europe’s position as a competitive hub for medical technologies. In addition, a critical concern raised by the Minister is the risk of losing companies to other jurisdictions. Today, CE marking procedures are complex and lengthy, creating barriers that discourage investment and innovation in the EU. Simplifying these processes is not only about efficiency: it means retaining the industrial base and expertise that make Europe a leader in medical technology. The Cypriot presidency has identified clear priorities: strengthening the EU’s strategic autonomy and resilience, and a future-oriented and predictable regulatory framework is an essential enabler to achieve these goals. By creating regulatory certainty, Europe can strengthen its ability to respond to health crises, reduce dependence on suppliers outside the EU and promote innovation within its own market.
The Cypriot presidency outlined a clear roadmap to move forward with the revision of MDR/IVDR. The focus will be on gathering input from Member States on the proposed reforms, with the aim of sharing consolidated feedback with the incoming Irish presidency in June. A ministerial discussion is planned during the June EPSCO Council meeting to provide political guidance. To speed up progress, discussions at technical level will address the topics in groups, allowing parallel workflows and faster consensus-building. This structured approach is designed to enable Ireland to begin working on a common position from the first day of its presidency, maintaining momentum and avoiding delays. The Minister’s remarks highlighted a sense of urgency and opportunity. With aligned political will, clear priorities and a structured process, the coming months represent a critical window to deliver meaningful reform. The stakes are high, not only for industry, but for patients who depend on timely access to safe and innovative medical devices.
Now the real challenge is to turn this consensus into concrete action in the interinstitutional negotiations that will begin in the coming days. It is hoped that they can conclude quickly, but political will and the ability to mediate between different needs will be necessary: those of patients, industry, regulatory authorities and Member States.
Leaving the conference, I had the feeling that there is finally a shared awareness of the problem and the need to act. It remains to be seen whether this awareness will translate into effective reforms. European health systems and patients cannot afford further delays.
Valeria Fagone, FTI Consulting
