The high-level conference, Medical Devices: Innovation and Patient Safety, held in Brussels on 16 March 2026, brought together policymakers, regulators, industry leaders and healthcare experts to address one of Europe’s most pressing healthcare challenges: how to ensure both innovation and patient safety in the medical devices sector.
Hosted by the European Commission, the high-level conference aimed to take stock of recent developments and outline the future direction of EU policy following the proposal to revise medical devices legislation adopted in December 2025.
A strategic sector under pressure
Opening the event, Olivér Várhelyi highlighted the central role of the sector in both healthcare and the economy. Europe’s medical devices market—the second largest globally—relies heavily on small and medium-sized enterprises and is key to delivering more personalised and effective treatments.
From AI-driven diagnostics to advanced implants, medical devices are transforming care by enabling earlier detection and tailored therapies. However, maintaining Europe’s leadership requires a regulatory environment that both protects patients and supports innovation.
Regulatory challenges and the need for reform
The current framework, introduced under Regulation (EU) 2017/745, was designed to strengthen safety and restore trust. Yet, years later, its implementation has exposed structural issues.
Speakers pointed to excessive administrative burden, repetitive procedures, and inconsistent interpretation of rules as key barriers. These challenges have slowed innovation and, in some cases, contributed to shortages of essential devices—ultimately impacting patient care.
“The unavailability of devices is itself a patient safety issue”, Várhelyi stressed
Spring 2026: a turning point for simplification
Ahead of the legislative revision, the Commission outlined a series of concrete policy changes and simplification measures expected between March and May 2026, aimed at making the system more efficient without lowering safety standards.
The reform package is built around key priorities: predictability, proportionality, innovation, regulatory coherence, and modernisation.
Among the main changes:
- Simplified certification system, including the removal of fixed maximum validity periods for certificates
- Reduced administrative burden, notably through lower frequency of safety reporting requirements
- Recognition of well-established technologies, allowing lighter requirements for long-used, safe devices
- Digitalisation of regulatory procedures, especially conformity assessments
- Stronger international alignment, including cooperation with global frameworks
To foster innovation, the EU will introduce:
- Dedicated pathways for orphan devices, addressing rare conditions
- Accelerated routes for breakthrough technologies, supported by new guidance pilots starting April 2026
- Integrated clinical assessment approaches, such as the COMBINE pilot for coordinated studies
At the same time, several implementing and delegated acts are expected in early 2026, including new rules on notified bodies and well-established technologies.
A major milestone will be the rollout of EUDAMED, with key modules becoming mandatory from 28 May 2026, marking a significant step toward a more transparent and digital regulatory system.
Established under the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) framework and reinforced by Regulation (EU) 2024/1860, EUDAMED introduces binding obligations for all stakeholders. Following the notice of functionality published on 27 November 2025, a six-month transition period applies, after which four core modules—Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance—become mandatory. These modules require registration of economic operators, ensure device traceability through UDI, and provide full visibility on certificates and conformity assessments, significantly strengthening EU-wide oversight and coordination.
Despite these simplifications, EU officials reiterated that high standards of safety and performance will remain fully intact, supported by a strengthened risk-based oversight system and faster response mechanisms to emerging risks.
The Commission emphasised that reform will only succeed with active involvement from all stakeholders: industry, regulators, healthcare professionals, researchers, and patients.
The conference itself reflected this diversity, bringing together representatives from EU institutions, Member States, and sector organisations to contribute to the ongoing policy debate.
Policy direction and next steps
Providing further context, Rainer Becker stressed the urgency of revising the system to ensure competitiveness, innovation, and access to devices, while safeguarding patient safety.
Efforts are also underway to strengthen expertise and coordination, including within the European Medicines Agency, and to ensure consistent implementation across Member States.
Balancing safety and speed
During the Q&A session, speakers reaffirmed that patient safety remains the guiding principle of all reforms. While procedures may be streamlined, safety standards will not be compromised.
Patient involvement is also being reinforced, including participation in expert and coordination groups.
Looking ahead
The conference made clear that Europe is entering a decisive phase in reshaping its medical devices framework. The challenge now is to deliver a system that is not only safe, but also agile, predictable, and capable of supporting innovation.
As policymakers, industry and healthcare stakeholders continue discussions in the coming months, the direction is set: simplification with purpose, ensuring that innovation reaches patients faster, without compromising trust or safety.
Learn more on the event page.