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Working with companies in the life sciences and technology sectors, Ellie Handy focuses on EU, Irish, and UK life sciences regulatory and commercial matters.

Ellie advises clients on regulatory issues including classification, biologics, orphans, paediatrics, GxP, market and data exclusivity, clinical research, labelling and promotion, reporting obligations, medical devices, and digital health. Ellie also advises companies in the food, cosmetic and consumer products sectors regarding regulatory compliance and borderline issues. Ellie provides advice in relation to corporate transactions and restructuring, in particular performing regulatory due diligence.

Ellie represents and works with a wide range of clients working in the life sciences and technology sectors on both contentious and non-contentious regulatory matters.

Ellie’s pro bono work includes assisting charities. In addition to her role at Covington, Ellie spent three years working life sciences regulatory practice in London.

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme

The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies.  It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI

The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop

The International Coalition of Medicines Regulatory Authorities (“ICMRA”) has published a report on the use of artificial intelligence (“AI”) to develop medicines (the “AI Report”) that provides a series of recommendations on how regulators and stakeholders can address challenges posed by AI.  The ICMRA notes that there are numerous opportunities to apply AI to medicines development, but that AI poses a number of challenges to existing regulatory frameworks.  The AI Report discusses these opportunities and challenges in detail based on several case studies, and provides a set of recommendations for implementation by the ICMRA and its member authorities, which includes the European Medicines Agency (the “EMA”), the USA’s Food and Drug Administration, and the World Health Organisation.  Based on the AI report, we expect to see an increased focus on adapting regulatory frameworks to deal with AI products going forwards both on an international and national level.

Continue Reading ICMRA Publishes Report and Recommendations on AI and Medicinal Products