Healthcare, competitiveness, innovation and simplification
News
20 May 2026
Healthcare, simplification

Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation. 

The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment. 

The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains. 

Biotechnology

The Biotech Act can strengthen Europe’s biotechnology ecosystem by making regulatory pathways more efficient and improving coordination at EU level. It can also support the responsible use of data and AI in research and manufacturing. These improvements will only have an impact if they are implemented consistently and work in practice for companies operating across several Member States.

Europe also needs incentives that match the scale and risk of biotechnology investment. A strengthened supplementary protection certificate extension would help ensure that faster procedures lead to more research, clinical activity and manufacturing in Europe. The framework should remain science based and open to international cooperation, while supporting diverse supply chains and the skills needed for long-term competitiveness.

Medical technology

The targeted revision of the MDR and IVDR is a welcome step toward a more workable medical technology framework. It would replace rigid certification cycles with risk-based reviews and make certain post-certification changes easier to manage. By recognising real-world evidence and creating clearer routes for breakthrough devices, the proposal would strengthen Europe’s position as a launch market for medical technologies.

Further changes would give companies greater certainty and better support innovation. Policymakers should clarify the rules for drug device combination products and ensure that reprocessing rules keep patient safety at the centre. Labelling changes should remain subject to appropriate oversight. Health institution exemptions should also be carefully balanced so they do not weaken patient safeguards or distort competition.

The MDR and IVDR must also align properly with wider EU legislation, including the AI Act and cybersecurity rules. Clearer timelines and a single reporting approach would help avoid duplication. A more flexible framework would make Europe a more attractive place to launch medical technologies and improve patient access across the EU.

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