Brussels, 16 March 2026
On 16 March 2026, three members of the EU4MEDTECH consortium attended the European Commission’s high-level conference “Medical Devices: Innovation and Patient Safety”, held at the Charlemagne Building in Brussels under the auspices of the Cypriot Presidency of the Council of the European Union.
The event, organised by DG SANTE, gathered EU regulatory authorities, European Parliament and Council representatives, and key stakeholder associations to address the Commission’s December 2025 legislative proposal for the revision of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) — a landmark initiative that directly shapes the regulatory landscape EU4MEDTECH is working to improve.
The conference featured a keynote address by EU Commissioner for Health and Animal Welfare Oliver Várhelyi, followed by three thematic breakout sessions focused on:
- Enhanced predictability for conformity assessments — combining regulatory certainty with flexibility
- Balancing Safety, Innovation and Trust — evidence-based approaches to medical devices and IVDs
- Breakthrough technologies for better care — translating regulatory guidance into practical clinical solutions
EU4MEDTECH was represented by Miro Vukovic from the University of Split School of Medicine (project coordinator institution), and by Renata Valsami and Nikos Dedes from the Greek Patients Association (GPA), the consortium’s patient organisation partner. Their participation ensured that both scientific-regulatory and patient-centred perspectives were brought to the table.
The conference provided a valuable opportunity to engage with the evolving EU regulatory framework and to position EU4MEDTECH’s work — including its lifecycle-oriented methodology, cloud-based digital platform, and real-world data integration approaches — within the broader European policy agenda on MedTech safety and innovation.
EU4MEDTECH will continue to monitor and engage with developments arising from the MDR/IVDR revision process as they unfold.
