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Michaela Herron, Head of Life Sciences with Jamie Gallagher, Partner, Regulatory and Product Liability, Mason Hayes & Curran
 Michaela Herron, Head of Life Sciences with Jamie Gallagher, Partner, Regulatory and Product Liability, Mason Hayes & Curran

With deep sector knowledge and practical insight, we guide clients through both regulatory change and day-to-day compliance. Our support helps businesses stay on course and move forward with confidence in Ireland, across the EU and in global markets. Our clients range from Fortune 100 leaders to emerging innovators.

We are the only firm in Ireland recognised in the Lexology Index Healthcare & Life Sciences Report for expertise across all life sciences sub-specialisms: regulatory, product liability defence, patent litigation and transactions.

Contact our team

Our Services

  • Product design, development and launch
  • Market access
  • Business model viability
  • Marketing and advertising
  • Intellectual property
  • Sustainability and environmental compliance
  • Supply chain and online sales
  • Product liability litigation
  • Patent litigation
  • Mergers and acquisitions
  • Corporate restructuring
  • Data privacy
  • Cyber security
  • Pricing and reimbursement
  • Regulatory investigations
  • Corrective actions and product recalls
  • CE marking of devices
  • Marketing & manufacturing licences

Recent Work

  • Advising Google LLC on the regulatory requirements and approval process under the Medical Devices Regulation (MDR) for their novel and first-of-its-kind Loss of Pulse Detection product.

  • Providing advice and training to a global healthcare company on advertising for connected medical devices to be marketed for retail purposes.

  • Acting for Neuraxpharm in the defence of patent infringement proceedings and bringing a counterclaim for invalidity relating to the launch of a generic MS treatment on the Irish market.

  • Advising a company on the CE marking of its first software medical device under EU medical devices legislation.

  • Advising a global medical device manufacturer on their AI Act compliance.

  • Providing detailed advice and critical assessment of a range of marketing and advertising communications and strategies for a major global coffee retailer. This included guidance on plastic, paper, waste, recycling, and other general environmental and sustainability claims.

  • Advising a baby monitor manufacturer on their engagement with the Health Products Regulated Authority (HPRA) concerning product classification and potential withdrawal of a product from EU markets.

Practice Areas

We have been home to Ireland’s only dedicated Life Sciences Regulatory team since 2019, providing trusted EU counsel to leading global Life Sciences and Technology companies. We also advise on wider issues shaping the sector, with particular strength at the intersection of Technology and Life Sciences, including digital health, AI and data privacy.

Contact our team