MedTech Europe recently published two position papers on the latest development on strength, resilience, and competitiveness policies in the medical technology sector.
With the first position paper released on 28 August 2025, MedTech welcomed the European Commission’s initiative to simplify EU digital legislation.
With the second publication from 10 September 2025, MedTech commented on the President of the European Commission’s State of the Union Address.
Position paper on simplification of EU digital legislation: AI Act and Cybersecurity
With its position paper “Simplification of EU digital legislation: MedTech Europe proposal to ensure coherent implementation”, the business association calls for a coherent approach to horizontal laws such as the AI Act, the Cybersecurity framework, and the Data Act, ensuring they complement rather than duplicate sectoral rules.
AI Act application to medical devices and IVDs
The AI Act, in force since August 2024 and applicable to the medical sector from August 2027, will cover AI-enabled medical technologies alongside MDR and IVDR. MedTech Europe warns that without adjustments, the AI Act risks duplicating requirements and overlooking sector-specific safeguards, leaving Europe behind global competitors.
MedTech Europe recommends:
- Extending the application date to August 2029, giving industry and authorities more time.
- Clarifying Notified Body designation under the AI Act.
- Providing a legal framework for pre-market clinical testing.
- Defining terms like “substantial modification” and “significant change” for AI-enabled devices.
- Avoiding duplicate risk management requirements already addressed in MDR/IVDR.
- Prioritising international standards such as ISO 14971 and ISO 13485 over EU-only approaches.
Cybersecurity: harmonised transposition and application across Member States
On cybersecurity, MedTech Europe cautions against making EU certification schemes mandatory, urging policymakers to preserve their voluntary character. For the NIS2 Directive, the industry calls for harmonised transposition and application across Member States, alongside simplification of definitions and streamlined reporting processes for security incidents.
Data Act: protecting patients and reducing Burdens
Concerning the Data Act, MedTech Europe warns that requiring access to raw and uninterpreted health data could lead to misinterpretation, security risks, and patient harm. To avoid this, medical technologies regulated under MDR and IVDR should be excluded from the Data Act’s sharing obligations.
Other recommendations include:
- Making data accessibility rules voluntary for medical devices, IVDs, and EHR systems.
- Clarifying the relationship with GDPR.
- Extending the application timeline to September 2029.
- Excluding legacy products to allow safe updates without unnecessary redesign.
- Strengthening protection for trade secrets and cybersecurity grounds to withhold data.
- Narrowing the definition of “EHR systems” to cover only longitudinal health repositories.
Reaction Statement to the President of the European Commission’s State of the Union Address
With its statement “MedTech Europe welcomes the European Commission’s emphasis on competitiveness and simplification outlined in today’s State of the Union Address speech”, MedTech reacted to the State of the Union Address speech held on 10 September. MedTech Europe welcomes the European Commission’s emphasis on competitiveness and simplification. At the same time, the industry calls for a fit‑for‑purpose regulatory and policy framework which can turns Europe a leader in health innovation and patient care.
“No health, no wealth”: real progress is measured through patient access to life-saving innovations
MedTech Europe demands health to be kept at the forefront of the EU political agenda. Actual progress and competitiveness must come with timely access to medical technologies and resilient and sustainable health systems that embrace digitalisation: “real progress will be measured by whether patients see faster access to life-saving innovations. After all, where there is no health, there is no wealth”, commented MedTech Europe CEO.
In addition, MedTech Europe calls for:
- A stronger Single Market and resilient supply chain will keep Europe’s health security intact.
- Sustainability and environmental goals that make sense for the people, the planet, and the industry.
- A EU budget that prioritize investments on high‑value medical technologies, as well as on interoperable digital and data infrastructure.
With the revision of the IVDR and MDR coming soon, stakeholders have a significant opportunity to participate to shaping the future of the European sector of medical technology.
If you do not want to miss any regulatory updates regarding MDR or IVDR, contact MDlaw.eu here or at mdlaw@obelis.net.
References
MedTech Europe (2025). The medical technology industry’s views on simplification of EU digital legislation. Retrieved on 02/09/2025.
MedTech Europe (2025). With health at its heart, Long Live Europe MedTech Europe’s reaction to the President of the European Commission’s State of the Union Address. Retrieved on 10/09/2025.
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