International Life Sciences Newsletter

What to expect in 2026 in the Life Sciences and Healthcare sector?

While the gradual roll-out of the EUDAMED database was expected to dominate the regulatory agenda, the European Commission’s proposed amendments to the MDR and IVDR are now set to become the most consequential legal development in the medical device sector since the regulations themselves entered into force.  

The proposals aim to simplify and recalibrate the existing framework, moving towards a more risk- and maturity-based regulatory approach. Although the scope of the changes is extensive and warrants detailed analysis, key highlights include the introduction of ‘well-established technology devices’ with targeted regulatory reliefs), removal of fixed expiry periods for certain CE certificates, amendments to classification rules, streamlining of manufacturers’ obligations (including QMS, certification models and clinical evaluation requirements), reform of the single-use and reprocessing regime, enhanced digitalisation, and a recalibration of authorised representatives’ and distributors’ liability. 

At the local level in Poland, the issue of upcoming changes to the advertising framework for pharmacies remains a key item on the legal agenda for 2026, with the recent CJEU ruling effectively repealing the long-standing ban on advertising pharmacies.

2026 is also set to be shaped by the EU Pharma Package, following the political agreement reached between Parliament and Council. The reform seeks to modernise the EU pharmaceutical framework by recalibrating regulatory data protection and market exclusivity, strengthening incentives for innovation while improving access and security of supply. Key elements include revised rules on conditional incentives, enhanced obligations to ensure medicine availability across Member States, updated provisions on generics and biosimilars, and a stronger focus on antimicrobial resistance. The coming year will be critical as implementation timelines, delegated acts and national positioning take shape. 

Another major development to watch in 2026 is the EU Biotech Act, aimed at boosting the competitiveness of Europe’s biotech and biopharmaceutical sector. The initiative focuses on streamlining regulatory pathways, facilitating clinical trials and manufacturing scale-up, improving access to funding, and reducing administrative burdens. By promoting innovation-friendly conditions while maintaining high safety standards, the Biotech Act signals a strategic shift towards strengthening Europe’s life sciences ecosystem. 

In Germany, 2026 will see the practical impact of standard contractual clauses introduced under the German Medical Research Act, intended to simplify and accelerate the negotiation of pharmaceutical clinical trial agreements nationwide, with similar standardisation efforts expected to extend to medical devices and IVDs during the course of the year. 

2026 will be shaped by the practical implementation phase of the EU Artificial Intelligence Act, with significant implications for the use of AI across the life sciences and healthcare sector. A wide range of AI-enabled medical devices, diagnostic tools and clinical decision-support systems are expected to qualify as high-risk AI systems, requiring extensive preparation in view of the high-risk obligations applicable from 2027, including requirements on risk management, data governance, human oversight and technical documentation, as well as the training of AI systems using health-related data and the deployment of such systems. A key legal challenge will be the alignment of these horizontal AI requirements with the existing sector-specific regulatory framework under the MDR and IVDR, where further EU-level clarifications are expected to support coherence with product safety and data protection law. 

In parallel, the European Health Data Space (EHDS) will further shape the EU framework for access to and secondary use of health data. In particular, the interaction between the EHDS, the GDPR and the AI Act — including questions of data availability, purpose limitation, anonymisation and governance models for research and AI training — is expected to gain further legal and strategic relevance in 2026. 

At national level, developments in Austria will primarily focus on the practical implementation of these EU requirements, especially in relation to the use of health data and AI-based applications. Data protection considerations and the integration of existing national health and supervisory structures into the evolving European regulatory framework are therefore likely to move further into focus.