EU change ‘to help medical-device firms’
Business-law firm Mason Hayes & Curran (MHC) says that new EU rules should make it easier for medical-device companies to plan product launches and budget for certification.
The firm has published its Digital Health Mid-year Review 2026, which 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.
The review says that the main changes to EU rules, set out in a European Commission implementing regulation published in May 2026, are expected to take effect from February 2027.
Conformity assessments
Michaela Herron (MHC partner and head of life sciences) said that medical-device and in vitro diagnostics manufacturers had long complained about slow and unpredictable conformity assessments.
Under EU rules, manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment, which usually involves an audit of the manufacturer's quality system.
“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," she stated.
Pace of change
The MHC review also covers AI classification, health-data processing, consumer law, product promotion, medical-device assessment, distributor obligations, and product liability.
The firm said that it was increasingly difficult to treat these areas as separate compliance workstreams.
"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," Herron stated.
Jamie Gallagher (MHC product regulatory and liability partner) said that several of this year’s developments had direct implications for how companies managed risk across the product lifecycle.
“This spans device classification and certification, product promotion, and the handling of liability claims years down the line,” he added, urging firms to check that that current practices reflected the updated rules.