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Hungarian supreme court on legal standing to challenge generic marketing authorisations

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

by Fruzsina Kónya

8 of 9 Insights

France renews its simplified anti-gift conventions – what life sciences companies operating in France need to know

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.

by Annabelle Lebaudy and Marine Boullenger

5 of 9 Insights

Taylor Wessing Advises Trivium eSolutions on the Launch of a Software-Engineering Platform with NetRom Software and Investcorp

by multiple authors

The new Product Liability Directive: three life sciences priorities before the 2026 deadline

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.

by Bartosz Świdrak

3 of 9 Insights

Update: AI-Enabled Medical Devices and IVDs Confirmed as “High-Risk”

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

4 of 9 Insights

Medical Cannabis Platforms Breach Advertising Ban

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

by Irina Rebin

7 of 9 Insights

Poland’s new AI systems act: a regulator and practical tools

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

by Bartosz Świdrak

9 of 9 Insights

Case law – VfGH on the eImpfpass and central vaccination register

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.

by Christopher Bakier

6 of 9 Insights

Tightening of the “BIS Rules” for Connected Vehicle Technologies in the U.S. – Challenge for global Automotive Companies with China-Nexus

Restrictions on “Chinese” vehicle technologies in the U.S. – What’s it about?

by Thomas Kahl and Dajin Lie

EHDS implementation: preparing for health data access and reuse

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.

by Christopher Bakier

2 of 9 Insights

CJEU on distributor's verification obligations under MDR

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.

by Irina Rebin

1 of 9 Insights