The UK exited the EU on 31st January 2020. By virtue of the transition period in the Withdrawal Agreement, EU law will continue to apply in and in relation to the UK only until the 31st December 2020. The EU Treaties, EU free movement rights and the general principles of EU law will then cease to apply in relation to the UK, and prior EU regulations will only continue to apply in domestic law (by virtue of the European Union (Withdrawal) Act 2018) insofar as they are not modified or revoked by regulations under that 2018 Act.
This article sets out the implications of Brexit on the UK Life Sciences industry as from the end of the transition period. For an explanation of the finalised Withdrawal Agreement, please see here.
This article is part of our Brexit series; medical devices businesses will be affected by many of the implications identified throughout this series and, in particular, our note on the English Intellectual Property law implications of Brexit and Brexit: Life Sciences Implications.
What is the current position?
As EU law will continue to apply in relation to the UK until 31 December 2020, during that so called transition period, the status quo will be maintained as much as possible, and in that short term the answer is that it should be "business as usual" for the medical devices sector in the UK. Plans need however to be made immediately, to the extent they are not already underway, for the significant changes that will occur thereafter. During the transition period, the nature of the relationship between the EU and the UK, will be determined, including that in relation to trade and regulation. .
The effects on the medical devices sector of Brexit are likely to be substantial. This is because the UK will no longer be part of the EU system, and products authorised in the UK will not be valid for sale in the EU – a separate certification from an EU based notified body will have to be obtained: a conformity assessment for Class II and Class III products and CE marking for Class I products.
Furthermore, manufacturers and distributors of medical devices or IVDs which do not have a registered office in EU27 will need to appoint an EAR or EC Rep (European Authorised Representative). The EC Rep is responsible for the products on the market in the name of the manufacturer and acts a contact for the authorities. Quality Management and safety officers will be required to ensure compliance under the Medical Devices Regulations.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (UK MDR 2019) amend UK legislation to reflect the new regime for the UK’s departure from the EU, and transpose all the key elements in EU legislation (such that the UK will be bound by the revised Regulations until 2022 at least, along the transitional timetable established for that legislation).
The exact ramifications of Brexit, in terms of what the relationship between the respective competent authorities and notified bodies will be post-Brexit, are yet to be determined and we therefore suggest the best policy at this time is to be prepared by keeping up to date as the process develops. Although many commentators have hoped for some degree of mutual recognition of standards, the UK government has indicated that this is not what they will be seeking in negotiations, and EU has given no indication that the UK will be treated as other than a third country like any other.
This article is part of our Brexit series