Sector

We advise both established and emerging manufacturers at every stage of the device lifecycle, helping them manage regulatory risks, anticipate challenges and maintain progress.

We combine deep knowledge of EU and international requirements with strong commercial insight. When issues arise, we act quickly to protect business interests and ensure continuity. In a sector where the margin for error is narrow, we provide the legal clarity and certainty clients need to move forward with confidence.

Latest

View All
Insights Medical Devices
Insights Medical Devices
Insights Medical Devices
Insights Pharma

Our Services

  • Product design, development and launch
  • Marketing and advertising compliance
  • Patent litigation
  • Artificial intelligence
  • Intellectual property
  • Supply chain disputes
  • Online sales and marketing
  • Product liability litigation
  • CE marking and regulatory compliance
  • Clinical investigations
  • Data privacy

Recent Work

  • Advising Fitbit LLC (now Google LLC) on the CE marking of its software medical device portfolio under EU medical devices legislation.

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

  • Advising Google LLC on the development of a number of software medical devices including its groundbreaking Loss of Pulse Detection feature.

  • Advising a global manufacturer of CGM sensors on marketing and advertising rules for medical devices in Ireland.

  • Representing a global manufacturer of breast implants in the defence of Irish product liability litigation proceedings.

  • Advising a global technology company on a research collaboration agreement with universities relating to the use of wearable devices.

  • Advising LetsGetChecked on its regulatory obligations under the IVDR and its telemedicine services.

  • Advising a global technology company on the classification of hearing assistance products including issues relating to data privacy, product classification and reimbursement.

  • Advising a top 10 Fortune 100 company on medical device regulatory requirements under the UK Medical Devices Regulation (MDR). This included advising on a large corporate merger and the drafting and implementation of quality agreements.

  • Advising a global baby monitoring manufacturer engaging with EU health product regulators concerning product classification and related corrective actions. This included the potential withdrawal of a baby monitor product from EU markets.

  • Advising a global healthcare company on the classification of its portfolio of software medical device applications in the EU and the UK. Also provided guidance regarding transition planning following Brexit and the coming into effect of the EU Medical Device Regulation.

Related Practice Areas

Dedicated Team

View All
Michaela Herron

Michaela Herron

Partner

Head of Life Sciences Regulatory, Product Liability

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

Jamie Gallagher

Partner

Regulatory, Product Liability

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

Anna Lundy

Of Counsel

Regulatory

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

Julie Austin

Partner

Cyber Security, Data Privacy

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

Niamh Caffrey

Partner

Co-Head of Tax

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

Oliver FitzGerald

Partner

Real Estate, Construction

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

Anne Harkin

Partner

Transactional

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

Wendy Hederman

Partner

Commercial

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

Brian Johnston

Partner

Data Privacy

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

Martin Kelleher

Partner

Head of Corporate Transactional

+353 86 810 7838 mkelleher@mhc.ie View Profile
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
Kevin Mangan

Kevin Mangan

Partner

Co-Head of Tax

+353 86 167 2150 kmangan@mhc.ie View Profile
Brian McElligott

Brian McElligott

Partner

Head of Artificial Intelligence

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

Nicholas Metcalfe

Partner

Corporate Governance

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

Jay Sattin

Partner

ESG

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