Health as a pillar of European competitiveness
In recent years, health has ceased to be viewed solely as an area of social policy. The experience of the COVID-19 pandemic, ongoing geopolitical tensions and intensifying global technological competition have clearly demonstrated that Europe’s capacity to design, manufacture and regulate innovative medical technologies is a core element of its strategic autonomy.
The Commission’s new measures explicitly position the health sector within the broader EU competitiveness and security agenda, identifying medical devices and in vitro diagnostics as critical components of this ecosystem.
System resilience as a regulatory objective
A central theme of the Commission’s communication is the concept of health system resilience. This notion extends well beyond crisis preparedness and encompasses the ability to ensure continuous availability of medical devices and diagnostics under conditions of regulatory, economic and supply chain pressure.
The Commission explicitly acknowledges that excessive regulatory complexity can undermine resilience if it leads to market withdrawals, reduced innovation incentives or supply disruptions. In this context, regulation is framed not only as a safeguard but also as a strategic instrument.
Regulatory innovation alongside technological innovation
The document places strong emphasis on the need for regulatory innovation to evolve in parallel with technological advances. MDR and IVDR are recognised as essential pillars of patient safety and market trust, yet also as frameworks that must continuously adapt to emerging technologies such as digital medical devices, artificial intelligence, and advanced molecular diagnostics.
Planned actions in this area include:
- further clarification and streamlining of regulatory requirements,
- improved integration of MDCG guidance into the regulatory framework,
- strengthened dialogue between regulators and innovators.
Targeted support for SMEs and MedTech startups
Small and medium-sized enterprises are explicitly recognised as key drivers of innovation in the MedTech sector, while also being the actors most exposed to the complexity and cost of regulatory compliance. The Commission’s measures therefore place particular emphasis on improving the operating environment for SMEs.
Proposed actions focus on:
- enhanced access to regulatory knowledge and guidance,
- early-stage regulatory support tools,
- increased predictability of conformity assessment pathways.
Although the package does not introduce immediate legislative changes, it clearly signals the direction of future MDR and IVDR refinements.
Health data and clinical evidence as foundations for innovation
Another important element of the initiative is the role of health data and clinical evidence generation. The Commission underlines the importance of better leveraging real-world data, registries and EU research infrastructure to support innovation and regulatory decision-making.
In the context of MDR and IVDR, this reinforces the growing importance of:
- post-market surveillance systems,
- post-market clinical investigations and performance studies,
- interoperable and high-quality data ecosystems.
Global competition and the attractiveness of the EU market
The communication openly acknowledges the global competitive environment in which the EU health sector operates. The Commission recognises that Europe competes for investment and innovation with regions offering more flexible or faster regulatory environments.
One of the explicit objectives of the new measures is therefore to strengthen the EU’s attractiveness as a location for the development, clinical validation and commercialisation of medical technologies, while maintaining high standards of safety and performance.
What this means for medical device and IVD manufacturers
For manufacturers, the Commission’s initiative serves as an important strategic signal rather than an immediate regulatory change. It confirms that future regulatory evolution will seek to balance safety, innovation and supply resilience more explicitly.
Manufacturers that proactively align their long-term regulatory, clinical and investment strategies with these priorities are likely to be better positioned as the EU regulatory framework continues to evolve.
Strategic conclusions
The new EU measures confirm that the health sector has become an integral part of the Union’s industrial, innovation and security policies. MDR and IVDR are no longer viewed as static legislative instruments, but as regulatory systems that must continuously adapt to technological progress and societal needs. For the medical device and IVD sector, this signals a gradual shift towards a more coherent, predictable and strategically aligned regulatory environment in the European Union.