Michaela Herron, partner and head of life sciences at Mason Hayes & Curran, said: “Medical device and in vitro diagnostics manufacturers have long complained about slow and unpredictable conformity assessments. These new rules impose maximum time caps on each stage of the process and require notified bodies to provide transparent, itemised cost estimates. For companies planning European product launches, that should mean fewer surprises on both timing and cost.”

The review examines the most significant legal and regulatory developments from the first half of 2026 and sets out what they mean for companies operating in the digital health and life sciences sectors.

This year’s edition ranges across AI classification, health data processing, consumer law, product promotion, medical device assessment, distributor obligations and product liability; areas that are increasingly difficult to treat as separate compliance workstreams. 

Ms Herron added: “The pace of regulatory change in this space has not slowed. Businesses need to keep their systems and frameworks under review to stay aligned with EU and Irish requirements as they continue to develop.”

The review also covers the European Commission’s draft guidelines on high-risk AI classification, published in May 2026, which address intended purpose, Annex III use cases and the circumstances in which providers may seek to avoid high-risk classification, while leaving some key questions, including Article 25 value chain responsibilities, for separate guidance.

It also considers the EDPB’s Guidelines 1/2026 on scientific research processing, adopted in April 2026, which clarify consent mechanisms, further processing obligations, storage limitation and the use of safeguards such as pseudonymisation.

From 27 September 2026, Ireland’s Empowering Consumers for the Green Transition Regulations will also restrict how businesses describe software updates and prohibit unverified environmental claims. The review also addresses HPRA guidance confirming that online content, including social media posts, influencer material and blog articles, is subject to the same advertising rules as traditional media. Finally, it considers recent CJEU judgments on distributor obligations under the MDR and on limitation periods under the Product Liability Directive.

Jamie Gallagher, product regulatory & liability partner at Mason Hayes & Curran, said: “Several of this year’s developments have direct implications for how companies manage risk across the product lifecycle. This spans device classification and certification, product promotion, and the handling of liability claims years down the line. Now is a good time to check that current practices reflect the updated rules.”