We were pleased to host the ABHI’s Brexit Seminar in June entitled “Politics, Policy, Business and Brexit - what next for MedTech?”, with panellists Charles Mayo (Partner, Simmons & Simmons), Alison Dennis (Partner, Fieldfisher LLP), Paul Bristow (Managing Director & Founder, PB Consulting), Steve Bridges (Independent European policy analyst), Sarah Collen (Senior Policy Manager, NHS European Office) and Mark Dayan (Policy & Public Affairs Analyst, Nuffield Trust). The panelists and audience engaged in a lively discussion on the issues facing the medical device industry following Brexit.
After some discussion regarding the different types of exit the UK could adopt and the likelihood of each option being chosen, conversation naturally turned to the issue of regulation. In particular, how UK medical device businesses would be able to bring their products to market in the UK and the EU following Brexit, the cost and administrative burden of ensuring compliance with two diverging regulatory regimes and the extent to which these issues would affect UK businesses’ ability to remain competitive in the market.
Whilst the regulatory position remains unclear, it was anticipated that some form of transitional period would be agreed to help to bridge the gap between pre and post Brexit regimes. It was expected that existing EU regulation would continue to apply in the UK, however, concern remained that amendments would be made to EU regulation in due course which would not be adopted into English law and, likewise, the UK may alter its legislation (eg to fit better with trade arrangements with other jurisdictions) such that, over time, the regimes would cease to be harmonised. A lack of harmonisation would impose the burden of having to ensure products comply with the requirements of multiple regulatory regimes and potentially delay market access. These issues could only be minimised if the UK continued effectively to track all EU medical device regulation, which would seem to frustrate many people’s motivation for voting in favour of Brexit (ie to cease to have EU laws applicable in the UK).
This issue is perhaps acutely demonstrated by reference to the new EU Medical Device Regulations which entered into force on 25 May 2017, but which will only have direct application across the EU in May 2020 for the Medical Devices Regulation (in order to allow for a three year transition period) and May 2022 for the In Vitro Diagnostics Regulation (in order to allow for a five year transition period). Consequently, while the MDR is in force in the UK now, by the date it is due actually to apply across the EU, the UK will no longer be a member state. If the UK government does not provide for the new Medical Device Regulations to become effective on the same day as the rest of the EU, from day one the UK will have a different regulatory position for medical devices than the remaining 27 EU countries.
This document (and any information accessed through links in this document) is provided for information purposes only and does not constitute legal advice. Professional legal advice should be obtained before taking or refraining from any action as a result of the contents of this document.