The Shape of Medical Devices Regulation in the United Kingdom? Brexit and Beyond

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.