Life Sciences Legal Lens Vol. 2

Medical device (and IVD) distributors. CJEU confirms that distributors need not repeat the manufacturer’s classification or conformity assessment, but must perform a “consistency check” for obvious inconsistencies.

EHDS implementation has begun. For life sciences companies, the key issue is how controlled access to health data, secondary use, AI training and data protection governance will work in practice – and what should be prepared before 2029.

The new EU Product Liability Directive applies to products placed on the market after 9 December 2026. Three changes call for decisions by life sciences companies now: software and AI as products, an eased burden of proof, and disclosure of internal evidence.

Digital Omnibus Update. More time (up to August 2028) yet confirming that AI-enabled medical devices and IVDs stay subject to the AI Act.

France enforces one of Europe's strictest anti-gift regimes, broadly prohibiting any benefit to healthcare professionals, in particular. Within this framework, simplified conventions offer a practical derogation — allowing companies to bundle hospitality declarations into a single filing. These conventions have just been renewed for another two years, with notable developments: COMIDENT (dental sector) joins as a signatory and a new two-month deadline applies for participant list submissions for certain types of convention.

The Austrian Constitutional Court rejected challenges to the eImpfpass and central vaccination register on procedural grounds. The decision leaves the register in place, but highlights the role of data protection remedies in digital health infrastructure.

Case law – German Federal Court of Justice (Bundesgerichtshof) – Online platforms brokering medical cannabis treatments breach the prohibition of public advertising under the German Healthcare Advertising Act

Case law – Hungarian Supreme Court (Kúria), precedent-setting judgment of 7 May 2026 – Kfv.37.810/2025/27 – On legal standing to challenge generic marketing authorisations

Poland’s new AI systems act builds the national framework for the EU AI Act. A new regulator is introduced, alongside two practical tools.