The Shape of Medical Devices Regulation in the United Kingdom? Brexit and Beyond
-
University of Birmingham
United Kingdom -
University of Birmingham United Kingdom
-
University of Liverpool United Kingdom
-
University of Birmingham United Kingdom
Abstract
The United Kingdom’s Medicines and Medical Devices Act (MMD Act) 2021 received royal assent on 11 February 2021. In its passage through parliament, as well as in the accompanying Explanatory Notes, the Act was framed by the government as a necessary post-Brexit bill. Yet prior to this, it was widely presumed that existing statutory instruments, enacted in 2019 to address medical devices regulation in anticipation of a ‘No Deal Brexit’, would provide the United Kingdom (UK) with the necessary legal framework through the transition period and beyond. The European Union (EU) exit legislation included provisions aimed at aligning domestic law with the new EU Medical Devices Regulation (EU MDR) and In Vitro Devices Regulation (EU IVDR) (which were initially due to be implemented during the EU exit transition period). However, just over a year later, at the end of 2020, while the 2021 Act was in the final stages of its parliamentary journey, legislation was introduced that reversed the provisions of the domestic medical device regulations concerning alignment for Great Britain (GB: England, Wales, and Scotland). The result is that the UK now has a dual system of regulation, with Northern Ireland (NI) being governed by the new EU MDR and EU IVDR and GB by older pre-Brexit (yet still EU-derived) law.
This article is an attempt to analyse the complex situation now in existence regarding the regulation of medical devices in the UK. To this end, we focus on three main issues. First, we examine the difficulties and challenges presented by the dual system of regulation between NI and GB, highlighting the potentially far-reaching consequences of regulatory divergence between different UK jurisdictions. Second, we ask whether, in the rush to new legislation in 2021, opportunities to properly reform the approach to medical devices were missed. Finally, we look to the future, focusing on the recent Medicine and Healthcare products Regulatory Agency Consultation on the future of medical devices regulation in the UK and the challenges and opportunities that remain.
Downloads
Author Biographies
Professor Muireann Quigley holds a Chair in Law, Medicine, and Technology at the University of Birmingham and is Principal Investigator on the Wellcome Trust funded Everyday Cyborgs 2.0 project which examines the legal and philosophical challenges arising from the joining of persons and bodies with attached and implanted medical devices. She has an interdisciplinary background which crosses medicine, ethics, and law. Professor Quigley has published on a range of topics at the intersection of law and bioethics, including reproduction, public health, the behavioural sciences, and property in the body and biomaterials. She is the author of Self-ownership, Property Rights, and the Human Body: A Legal and Philosophical Analysis, published by Cambridge University Press in 2018. She has recently been appointed to the a member of the Interim Devices Working Group, which provides independent, external expert input and advice relating to medical devices to the Medicines and Healthcare products Regulatory Agency in the United Kingdom.
Dr Laura Downey is a Research Fellow in Law on the Wellcome Trust funded Everyday Cyborgs 2.0: Law’s Boundary Work and Alternative Legal Futures project. Her research interests lie in the interaction between law, technology, and society with a focus on medicine and biotechnology. Her work on the Everyday Cyborgs 2.0 project has concentrated on the shifting medical device regulatory landscape in the United Kingdom and European Union post-Brexit, and the specific legal challenges facing everyday cyborgs or integrated persons (that is, persons with attached or implanted medical devices). Before she started work on the project, Dr Downey completed her PhD at the University of Edinburgh looking at the dynamics of emergence of legal concepts – specifically identity – at the nexus of law and technology.
Dr Zaina Mahmoud is a lecturer in law at the University of Liverpool. Her research compares the impact of legal and health regulatory frameworks on reproductive rights and reproductive health, taking an empirical approach to enhance the socio-legal analytical component of her work.
Professor of Health Care Law and Director of Centre for Health Law Science and Policy at the University of Birmingham
