This Mid-year Review highlights the most significant legal and regulatory developments from the first six months of 2026, providing a critical pulse check for companies navigating these shifting tides:
- High-risk AI Act classification metrics: A review of the European Commission’s landmark draft guidelines defining high-risk AI parameters, focusing on intended purpose exclusions, complex architectures and biometric data boundaries.
- EDPB scientific research processing rules: Key takeaways from newly adopted guidelines clarifying data subject consent mechanisms, storage limits for future projects and purpose compatibility under the GDPR.
- Strict software update protections: The impending arrival of stricter software update disclosures and anti-greenwashing measures coming into effect under the Empowering Consumers for the Green Transition Regulations.
- Digital medicine promotion on social media: New guidance from the Health Products Regulatory Authority (HPRA) targeting the active oversight and evolving boundaries of digital marketing and public-facing treatment promotion on social media platforms.
- Uniform medtech assessment frameworks: The European Commission’s introduction of mandatory maximum assessment timelines and uniform pricing transparency rules for notified bodies under Implementing Regulation (EU) 2026/977.
- Downstream supply chain diligence: Vital clarification from the Court of Justice of the European Union in Dürr Dental v Cattani regarding the exact scope of a distributor’s formal verification and “due care” obligations under the MDR.
Our Mid-year Review serves as a valuable resource to help your business maintain compliance and charter a clear strategic heading for the remainder of 2026 and beyond.