The European Commission opened recently a public consultation on the European Innovation Act. This imitative aims at addressing certain issues faced by companies in the EU. In particular, some aspects which the Innovation Act could tackle include regulatory fragmentation, the need for more innovation-friendly regulatory frameworks and opportunities to test innovative solutions, access to finance, access to research, insufficient commercial exploitation, and improved coordination of innovation policies.
MedTech Europe published their position and recommendations submitted in the consultation, which closed on 3 October 2025.
Creation of an enabling framework without hampering sectoral reforms
MedTech Europe framework-level recommendations include:
- Recognising medical technologies as a critical sector for Europe’s future. Policymakers should recognise medical technologies as a strategic sector in the European Innovation Act.
- Facilitating access to finance, and supporting access to EU and national funds, especially for SMEs.
- Enabling talent attraction and retention, including employee ownership. This can be implemented by expending EU-support training in regulatory science, clinical evidence, AI/data, cybersecurity, sustainability, and similar.
- Coordinating innovation policies among Member States and with the EU. With particular focus on healthcare, MedTech Europe suggest the establishment of a health innovation coordination platform and the introduction of a “5th freedom” for research and innovation.
- FP10 and the Innovation Act as mutually reinforcing pillars. MedTech highlights the importance of coordinating the European Innovation Act with FP10.
Nurturing medical technology innovation through sectorial reforms and simplification
The European Innovation Act should support and complement existing reforms (such as the revision of the EU MDR and IVDR) and the regulatory simplification should remain within ongoing sector-specific legislative reviews. MedTech Europe recommends that the Act streamlines the path from research to market, promote interoperable innovation frameworks, and foster a supportive environment for innovation. Recognising the medical technology industry as a strategic sector and creating an innovation-friendly environment that speeds up market uptake is essential to Europe’s global health leadership and long-term prosperity.
In terms of coordination, the EU should establish formal coordination across Directorates-General to align horizontal policies with healthcare innovation needs, including regulatory sandboxes for medical technologies, interoperable digital health testbeds, harmonised standards and guidance, and improved certification capacity and predictability.
Additionally, other aspects to address concern:
- Access to Research and Technology Organizations (RTOs) and clinical infrastructures, where a “single-door” mechanism should allow fair and transparent access to public research and clinical infrastructures, benefiting MedTech innovators.
- Commercialisation of publicly funded R&I which should promote collaboration between academia, industry, and healthcare with simplified tech transfer and IP management frameworks to support innovation uptake.
- Innovation policy, which should pay stronger attention to ensuring continuity. MedTech outlines that funding should support not just early research but also later stages like regulatory readiness and market alignment, especially for SMEs.
Lastly, MedTech points out that public procurement is critical for early adoption and scaling of medical technologies but remains underused across Europe. To improve this, some recommendations include:
- Adoption of value-based procurement as standard
- Implementation of innovation-friendly procurement practices
- Cut of administrative burdens
- Support of SME participation
- No rigid EU-Origin preference
MedTech concludes that the European Innovation Act is a key opportunity to strengthen Europe’s innovation ecosystem, competitiveness, health resilience, and technological leadership. However, the policy must focus on accelerating the translation of innovation, such as in medical technology, into real-world impact.
Do you want to know more? Contact us for any questions on medical devices compliance.
References:
MedTech (2025). MedTech Europe responds to the European Innovation Act Call for Evidence. Retrieved on 10/10/2025.
European Commission (2025). Have Your Say. European Innovation Act. Retrieved on 10/10/2025.
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