Sector

With market-leading experience across Health, Life Sciences and Technology regulation, we identify risks early and equip clients with scalable compliance strategies that support growth and investment.

Where scrutiny or disputes arise, we act quickly to protect business interests. In a sector where innovation moves ahead of regulation, we provide practical legal solutions that allow for safe, sustainable progress.

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Insights Pharma
Insights Digital Health
Insights Digital Health
Insights Digital Health

Our Services

  • Research and development
  • Market access
  • Clinical investigations
  • Conformity assessment procedures and CE marking
  • Marketing and advertising
  • MDR, IVDR, GDPR and EU AI Act compliance planning
  • Engaging with regulators including the Health Products Regulatory Authority and Data Protection Commissioner

Recent Work

  • Advising LetsGetChecked on its home test kit and telemedicine services.

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

  • Advising Fitbit LLC (now Google LLC) on the CE marking of software medical devices under the Medical Devices Regulation (MDR).

  • Advising Google LLC on its regulatory roadmap and approval process for its groundbreaking Loss of Pulse Detection feature.

  • Advising a baby wearable monitor manufacturer through an investigation by regulators on product classification and regarding the potential withdrawal of its product from EU markets.

  • Advising various providers of digital health and telemedicine platforms on Irish regulations governing online medical consultations and prescription medicines.

  • Advising a digital health company developing a VR-enabled mental health app on its classification as a software medical device and requirements under EU medical device frameworks.

Related Practice Areas

Dedicated Team

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Michaela Herron

Michaela Herron

Partner

Head of Life Sciences Regulatory, Product Liability

+353 86 607 6005 mherron@mhc.ie View Profile on MHC.ie
Jamie Gallagher

Jamie Gallagher

Partner

Regulatory, Product Liability

+353 86 068 9361 jamesgallagher@mhc.ie View Profile on MHC.ie
Anna Lundy

Anna Lundy

Of Counsel

Regulatory

+353 868307506 alundy@mhc.ie View Profile on MHC.ie
Julie Austin

Julie Austin

Partner

Cyber Security, Data Privacy

+353 86 137 2136 jaustin@MHC.ie View Profile on MHC.ie
Niamh Caffrey

Niamh Caffrey

Partner

Co-Head of Tax

+353 86 032 4193 ncaffrey@mhc.ie View Profile on MHC.ie
Oliver FitzGerald

Oliver FitzGerald

Partner

Real Estate, Construction

+353 86 027 8838 ofitzgerald@mhc.ie View Profile on MHC.ie
Anne Harkin

Anne Harkin

Partner

Transactional

+353 86 029 5141 aharkin@mhc.ie View Profile on MHC.ie
Wendy Hederman

Wendy Hederman

Partner

Commercial

+353 86 046 4404 whederman@mhc.ie View Profile on MHC.ie
Brian Johnston

Brian Johnston

Partner

Data Privacy

+353 86 776 1771 bjohnston@mhc.ie View Profile on MHC.ie
Martin Kelleher

Martin Kelleher

Partner

Head of Corporate Transactional

+353 86 810 7838 mkelleher@mhc.ie View Profile on MHC.ie
Gerard Kelly SC

Gerard Kelly SC

Partner

Head of Intellectual Property, Co-Head of Dispute Resolution

+353 86 820 8066 gkelly@mhc.ie View Profile on MHC.ie
Hazel McDwyer

Hazel McDwyer

Partner

Intellectual Property

+353 86 108 3861 hmcdwyer@mhc.ie View Profile on MHC.ie
Brian McElligott

Brian McElligott

Partner

Head of Artificial Intelligence

+353 86 150 4771 brianmcelligott@mhc.ie View Profile on MHC.ie
Nicholas Metcalfe

Nicholas Metcalfe

Partner

Corporate Governance

+353 86 047 4602 nmetcalfe@mhc.ie View Profile on MHC.ie
Jay Sattin

Jay Sattin

Partner

ESG

+353 86 078 8295 jsattin@mhc.ie View Profile on MHC.ie