Europe’s competitive future: Modern regulation for drug-device innovation

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Roche in Europe

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Agile, coherent, and well-resourced regulation is essential to ensure innovation happens in Europe, not just for Europe.

Europe stands at a turning point for life sciences. The next wave of medical innovation will be driven by technologies that combine medicines, diagnostics, devices and digital tools, from AI enabled companion diagnostics to connected drug delivery systems that support personalised healthcare. These solutions evolve quickly, yet, current regulatory frameworks were not built for keeping pace with this speed.

This gap is already leading to delays and uncertainty. Regardless important steps ahead in this domain, an EFPIA survey on In Vitro Diagnostic Regulation (IVDR) found that 43% of companies experienced delays of 6-12 months under current rules, and nearly half expect similar delays to persist over the next years1.

Modern, predictable, and risk-based regulation can help close this gap, ensuring patients gain faster access to innovative solutions. This approach aligns with the European Commission’s Better Regulation agenda, which stresses that “simple, lighter, and faster EU regulation” is key to Europe’s competitiveness2. Europe’s Life Sciences Strategy, published in July 2025, reinforce this ambition and calls for reforms to make the EU “the world’s most attractive place for life sciences by 20303”.

An EFPIA survey on In Vitro Diagnostic Regulation (IVDR) found that 43% of companies experienced delays of 6-12 months under current rules, and nearly half expect similar delays to persist over the next years.

Europe’s policy moment

Europe’s leadership in health innovation will depend on how effectively it translates this ambition into action. The Draghi report4 on European competitiveness called for “simplification” and “regulatory coherence” as central enablers. Similarly, Commissioner Várhelyi has stressed that

We have the task of bringing together pharmaceuticals, medical devices, artificial intelligence and big data in a more agile regulatory environment if we want to unlock the brand new therapies, technologies and care models to serve the European people⁵.

At present, frameworks such as the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and Clinical Trials Regulation (CTR) are not well interconnected and navigating this fragmentation can slow down research and delay access for patients.

Europe’s ability to lead in life sciences will depend on how effectively Pharma and Device regulations work together. With growing political attention on competitiveness, simplification and coherence, now is the right time to align these systems and support the next generation of integrated healthcare solutions6.

Products that combine medicines, devices and diagnostics often face fragmented oversight, with different authorities or bodies responsible for assessing different parts of the same product.

Europe can build on its strong regulatory foundations by improving predictability and coordination. Establishing a single orchestrating body, potentially within a well-resourced European Medicines Agency (EMA), would help streamline decision-making and ensure consistent standards across the EU. Enhanced, end-to-end Scientific Advice (SA) should allow the EMA, National Competent Authorities, Notified Bodies (NBs), and developers to collaborate from early development to post-market review7. Strengthening cooperation between all these stakeholders would translate ambition into practical, predictable pathways that support innovation end to end.

Efficiency is central to Europe’s competitiveness. Multi-country studies that involve both medicines and devices can be accelerated through greater harmonisation, one submission pathway and a risk-based approach that maintains safety while reducing unnecessary complexity.

The responses to the Commission’s public consultations on MDR and IVDR describe various measures8,9,10,11 to ensure streamlined processes and simplification. Introducing dedicated breakthrough pathways for integrated solutions targeting serious or rare conditions would help bring transformative treatments to patients more quickly, strengthening Europe’s ability to attract high-impact research12.

Expanding regulatory sandboxes to test solutions for drug–MDR/IVDR challenges, particularly for cutting-edge device technologies, would allow regulators to evaluate new approaches in a controlled setting, supporting innovation while maintaining safety13.

Connecting digital systems and data bases such as the Clinical Trials Information System (CTIS) and EUDAMED would cut duplication and enable parallel reviews, an improvement also investigated by the COMBINE programme14,15.

Long-term success depends on a capable and connected regulatory ecosystem.

The newly established EU fee regulation should ensure that the EMA, and National Authorities have the resources they need to evaluate increasingly complex and integrated technologies16.

Investments in interoperable digital platforms and future databases will support transparency and more efficient knowledge-sharing across authorities. Stronger engagement in international harmonisation efforts, through the International Council for Harmonisation (ICH), the International Medical Device Regulators Forum (IMDRF) and the International Organization for Standardization (ISO)17 will ensure Europe remains aligned with global best practices and retains its leadership role.

As Commissioner Várhelyi noted, Europe must “simplify, cut red tape and make procedures more harmonised, while keeping patient safety at the centre18”, a principle that should guide future reforms.

A clear path forward for Europe’s leadership in innovation

Europe has already built strong scientific and regulatory foundations. The next step is to reinforce its regulatory environment so it is coordinated, efficient and ready for the technologies of the future.

By improving governance, streamlining processes, and reinforcing regulatory capacity, the EU can ensure regulation becomes a driver for innovation, not a barrier to it. This is essential not only for patients, but for Europe’s long term competitiveness.

Without action, Europe risks depending on other regions for innovation. With the right reforms, it can remain a global hub of excellence. Aligning MDR and IVDR reform with the Life Sciences Strategy19, the Biotech Act and necessary changes to the clinical trial framework, will help ensure that global breakthrough health solutions continue to be developed and launched in Europe — supporting patients, strengthening industry and securing Europe’s global leadership.

References

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Bold actions to drive EU regulation for drug-device solutions

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Europe’s competitive future: Modern regulation for drug-device innovation

Roche in Europe

Europe’s policy moment

1. End-to-end governance: unified oversight and shared accountability

2. Streamline processes: faster, simpler, and risk-based approaches

3. Strong foundations: expertise, infrastructure, and global alignment

A clear path forward for Europe’s leadership in innovation

Downloads

Bold actions to drive EU regulation for drug-device solutions

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