The Summit Program

• Moderator

The attractiveness of Europe for Medtech, the impact of the EU MDR/IVDR and the AI Act on innovation and the road to an innovation enabling regulatory system in Europe will be discussed.

Presentations will address the attractiveness of Europe for the SME ecosystem in MedTech innovation, the ability to foster timely accessability to innovative healthcare solutions across Europe. The impact of the MDR/IVDR for SME ecosystem, the state of play on concrete impact and the road ahead towards an innovation enabling regulatory in Europe will be part of the summit scene settings.

The European Commission will present ongoing initiatives and longer-term policy considerations, drawing on surveys and the recent evaluation of the MDR/IVDR.

The Summit will discuss with first hand information the latest development in the field of Breakthrough MD Guidance under development, the interplay with AI act and the further implementation of Structured dialogue and scientific advice to support of an innovation enabling regulatory environment and to go from Policy to Practice.

PRESENTATIONS:

• Attractiveness of Europe for SME driven Medical Technology Innovation. – Deloitte
• Impact of MDR/IVDR on Innovation (SME) and supportive initiatives – EY Survey  & NOBOCAP Pulse Report
• Legislative and Non-legislative EU Policy initiatives – European Commission – Flora Giorgio, Head Unit D3 Medical Devices

The Task Force on Breakthrough MD guidance co-chairs of European Commission and Competent Authorities,  will provide 1st hand insights and discuss the latest development and plans in building out the guidance  and planned implementation.

Within the current regulatory MDR/IVDR framework provision will be put forward in support of a streamlined process with NB, on a balanced pre-post market clinical and non-clinical evidence generation and provision specific related to SME.  Considerations on SME supportive initiatives of the European Innovation Council and SME executive Agency (EISMEA) will be discussed. The specific value and how the guidance compares to Breakthrough innovation pathways in other jurisdictions will be open for a moderated discussion.

PANEL:

• MDCG-New Technologies - TF Breakthrough MD
  Co-Chair Donal B O’Connor, Co-Chair/Clinical Manager - Medical Devices Health Products Regulatory Authority (HPRA), Ireland
• European Innovation Council and SMEs
  Executive Agency (EISMEA) Federica Zanca - Program Manager Medical Imaging and AI in Healthcare
• Notified Body / NBCG-Med (TBC)
• European Commission

The EC will provide further details on the speaker as well as an update on the implementation of the AI Act and different initiatives to support/ensure a smooth interplay with MDR/IVDR, incl. FAQ

• Presentation : DG CNET – (TBC)

AI Medical Technologies are transforming healthcare and are regulated in the EU under both the AI Act and MDR/IVDR. To help SME innovators navigate these frameworks, the panel will discuss specific provisions on testing and how to align with the conformity assessment requirements by both regulations. The discussion will feature the MDCG Co-Chair of New Technologies, experts from AI labs and certification bodies, as well as SME representatives who will share their experience and expertise in fostering conformity assessment in practice.

PANEL:

• MDCG – New Technologies Co-Chair, Mariana Madureira, INFARMED, Portugal
• AI LAB and Certification: - Alexander von Janowski, TEF-HEALTH / TUV-LAB AI
• Notified Body: Geofrey Devisscher, Head of NB SGS - NoBoCap partner
• SME perspective: Miguel Amador, Chief Innovation Officer Complear – Nobocap partner

The EU MDR/IVDR provide for structured dialogue with notified bodies, access to scientific advice, and certification with provisions. However, uncertainties remain regarding implementation, the acceptance of data and evidence in practice, and their utility for SMEs.

Recent MDCG guidance on Orphan Medical Devices, Breakthrough Medical Devices, and joint scientific consultations (in EU HTAR)  introduces further provisions to enable structured dialogue and access to scientific advice. These cover evidence expectations for CE certification (with provisions) in both pre- and post-market phases, as well as comparative evidence generation post-market to support joint clinical assessments and inform health technology assessments.

The panel will provide insights into EU and countries policy consideration and implementation initiatives in practice and have an open discussion on the way forward and challenges overcome to make structured dialogue and certification with provisions more accessible, and provide a view on the interplay with scientific advice opportunities. Leading Competent Authority and notified body will share their perspectives, with specific consideration for SME-driven (breakthrough) innovation. The utility will be discussed and compared to other jurisdictions incl. US-FDA.

PANEL:

• Competent Authority: Dr. Matthias Neumann – MDCG NET and TF Breakthrough Member – Federal Ministry of Health, Germany

• Notified Body: Richard Holborow - Global Head of Clinical Compliance - BSI

• EMA – Expert Panel (TBC)

• SME Innovator: Rapporteur Pre-Conference Workshop

With an additional 6 months in the project the future planned backbone services and availability of tools will be indicated by NOBOCAP Consortium project partners as well as the planned continuation of services after Nobocap project ends.

By ROHEALTH, MEDVIA, EU4HS, SGS , … (TBC)

Innovation hubs/clusters, member of the Community will express their planned initiatives to foster preparedness in unlocking the EU regulation on innovation and contribute to creating of an innovation enabling regulatory environment. 4 of Members Innovation Hubs with on stage with others in room on the new initiatives presented, possibly with a survey before the summit. (TBC)

With the NOBOCAP project finishing early 2026, an updated will be provided on the plans taking the Nobocap initiatives and community of innovation hubs/clusters and partners forward.

The EU Commission will highlight the policy consideration on evolving the EU legislative frameworks and flagships in the creation of a competitive European SME driven innovation enabling environment enabling a timely accessibility of innovative solutions of value while safeguarding patient and population health.  Closing remarks will be given.

• Mr. Rainer Becker – Director DG SANTE Medical Products and Innovation