The impact of brexit on medical devices regulation in the united kingdom

  • Dominican Republic
  • 10/31/2019
  • https://www.morganlewis.com

From disrupting the supply of medical devices to affecting how they are regulated and sold in the United Kingdom (UK), Brexit could carry significant implications for UK healthcare and trade.

This note summarizes (i) the current status of Brexit, (ii) some of the key features of the current regulatory system for medical devices in the UK (as an EU member state) and the rest of the European Union (EU), (iii) how a so-called “no-deal Brexit” could impact the sale of medical devices in the UK and EU, and (iv) options for cooperation between the UK and EU post-Brexit.

BREXIT AND MEDICAL DEVICES
At the time of writing, the terms and date of the UK’s exit from the European Union (Brexit) are uncertain, with the withdrawal terms agreed between the UK government and the European Union, but not ratified by the UK Parliament, and with an early UK election likely to take place in December 2019.

Brexit will likely impact most, if not all segments of the UK economy with the UK government stating that “when the UK ceases to be a member of the EU in October 2019 all rights and reciprocal arrangements with the EU end.”[1] This will likely disrupt the supply of various goods and services to and from the UK with the impact on the supply of medicines and medical devices being particularly problematic.[2]

Besides immediate disruptions to the supply of medicines, Brexit would also have long-term repercussions on the way medical devices3 are regulated and sold in the UK, with potentially significant ramifications on UK healthcare and trade. Certain key issues regarding Brexit and the regulation and trade of medical devices include: (i) medical devices approved by Notified Bodies (see further point 5 below) based in the UK requiring new “CE-marks” in the EU post-Brexit; (ii) medical devices approved in the EU requiring parallel registration in the UK by a Notified Body with a UK presence, prior to being placed on the UK market; and (iii) the UK regulator of medical devices losing access to post-market safety data shared by medical device regulators across EU member states.
THE UNITED KINGDOM’S CURRENT REGULATORY SYSTEM FOR MEDICAL DEVICES
In the UK, the Medicines and Healthcare products Regulatory Authority (MHRA) has overall responsibility for licensing and regulating medical devices although not for the actual award by Notified Bodies of the CE mark, as described below at point 5. Currently, all medical device products and in vitro diagnostic devices must meet essential requirements of all relevant European medical device directives (Directives),[4] which outline the safety and performance requirements for medical devices in the EU and the European Economic Area (EEA). Medical devices that are certified as conforming to the Directives are marked with the designation “CE” (Conformité Européene) and can be marketed and sold anywhere in the EU and the EEA. It is a legal requirement to have a CE mark in order to place a medical device on the market in the EU and the EEA.

Under the Directives, while manufacturers of lower risk devices can self-certify by way of a Declaration of Conformity, higher-risk devices (Class II and III medical devices and certain in vitro diagnostic devices) must be certified by an independent conformity assessment body (Notified Body). This is an organisation designated by an EU member state (in the UK by the MHRA) to assess whether manufacturers and their medical devices meet the requirements set out in legislation. Across the EU, there are approximately 50 Notified Bodies; of these, five are in the UK.

Two new EU regulations will apply in EU member states by May 2020 (the Medical Devices Regulation)[5] and by May 2022 (the In Vitro Diagnostics Regulation)[6] (together the New Regulations). The New Regulations stipulate inter alia for: (i) stricter ex-ante control for high-risk devices (via a new pre-market scrutiny mechanism involving a pool of experts at the EU level); (ii) a comprehensive EU database on medical devices and a device tracing system; (iii) an EU-wide coordinated procedure for authorising multi-centre clinical investigations; (iv) stronger post-market surveillance requirements for manufacturers; and (v) improved coordination mechanisms between EU member states regarding vigilance and market surveillance.

The UK government plans to implement a system that mirrors (as far as practicable) the New Regulations.
THE IMPACT OF A NO-DEAL BREXIT ON THE SALE OF MEDICAL DEVICES
In the event of a no-deal Brexit (and without any other sector-specific arrangements in place) the UK could not continue to participate in the shared EU regulatory framework. For example, the UK-based Notified Bodies would no longer be able to assess the conformity of medical devices and grant the CE- mark allowing them to enter the EU market. While the MHRA would continue to perform its post-market surveillance of medical devices on the UK market, it could no longer be involved in the assessment of medical device safety through the EU regulatory network and would no longer receive post-market safety data that is currently shared across all members of the European regulatory network for devices. In anticipation of Brexit however, BSI, one of the UK’s largest notified bodies serving the medical devices sector, gained designation in the Netherlands to avoid the risk of it being no longer available to grant CE-marks under the Directives and the Regulations.

After a no-deal Brexit, all medical devices would need to be registered with the MHRA prior to being placed on the UK market, in addition to parallel registration requirements in the EU. The UK government has provided for a grace period (ranging from four to 12 months depending on the classification of the medical device) in order to allow time for compliance with the new registration process. The UK government states that where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a “UK Responsible Person” established in the UK and with a UK registered address who will take responsibility for the product in the UK.

The UK government states that it will not require any changes to the labelling of affected medical device products (e.g., to reflect the role of this “UK Responsible Person”) and that the UK will continue to accept labelling in the English language on condition that information complies with all UK requirements.

The UK government has also stated that for a time-limited period it will continue to recognise the CE-mark on medical devices and allow such devices to be placed on the UK market, provided they meet all EU requirements. The UK government noted that in due course it would consult and provide further detail on the future process after this temporary period.
OPTIONS FOR POST-BREXIT COOPERATION
The UK government under current Prime Minister Boris Johnson agreed with the European Commission and the other 27 EU member states for the UK’s exit from the European Union (the Withdrawal Agreement) on 17 October 2019.

The Withdrawal Agreement stipulates inter alia for the continued application of EU law and the continued jurisdiction of EU courts over the UK for a transition period until the end of December 2020 (with the possibility of a further two-year extension) during which the UK would not have membership of the EU institutions. During the transition period the UK and the EU would agree to a more permanent arrangement, as outlined in high-level terms in the political declaration on the future relationship between the UK and the EU (the Political Declaration). With respect to medical devices, during the transition period, there would continue to be free movement of medical devices between the UK and the EU. Following the transition period, the Political Declaration stated that the UK and EU would “explore the possibility of cooperation of United Kingdom authorities with EU agencies such as the European Medicines Agency”.[7] Similar regulatory cooperation with respect to medical devices could also have been envisaged.

While the Withdrawal Agreement and the Political Declaration have not yet been ratified by the UK Parliament and while they may yet be subject to further change, there remain broadly two possible outcomes for the regulation of medical devices in the UK following Brexit: one in which the UK remains within the EU regulatory system and another in which the MHRA becomes a sovereign regulator.

Remaining within the EU regulatory system would closely mirror the current status quo. However, the EU has stated that after Brexit the UK would be excluded from participating in EU institutions, agencies, or bodies.[8] Remaining within the EU regulatory system is also not the stated objective of the current UK government.

The second outcome, in which the MHRA becomes a separate sovereign regulator, could potentially also entail significant regulatory alignment, e.g., via a UK-EU Mutual Recognition Agreement. Mutual Recognition Agreements are bilateral agreements that are primarily used in trade negotiations to promote trade and facilitate market access in goods between the EU and third countries. Such agreements set out where regulators will accept the test results and/or licensing processes of another country and vice versa. For example, in relation to medicinal products, the national regulators of Switzerland, Canada, and the United States cooperate with the European Medicines Agency (the EMA) pursuant to Mutual Recognition Agreements with the EU. A potential Mutual Recognition Agreement for medical devices between the UK and the EU could involve, among other things, the UK continuing its role in appointing Notified Bodies and in participating in assessing medical devices.

The British Medical Association, a professional association and registered trade union for doctors in the United Kingdom, (the BMA) has advocated for the continued mutual recognition of the CE-marking on medical devices in the UK and EU member states after Brexit.[9] The BMA argues that continued collaboration between the UK and the EU on medical devices would: (i) limit potential delays incurred by device manufacturers seeking a license for their products in the UK, and ensure timely access to medical devices; (ii) maintain EU access to the extensive network of expertise in the UK in medical devices; and (iii) ensure that medical devices developed in the UK can reach EU citizens quickly. [10]

Considering (i) the potentially significant healthcare and economic ramifications that a disruption to the trade in medical devices could entail; (ii) the fact that there is UK industry support for continued collaboration with the EU in the regulation of medical devices; (iii) that the UK government has stated that it will continue to incorporate the Directives and New Regulations in national law as far as practicable; and ultimately (iv) the fact that both the EU and the UK could benefit from continued close trade ties, from the sharing of expertise, and from close regulatory cooperation – there may indeed be scope for a formal UK-EU agreement on the regulation and trade of medical devices post-Brexit. The depth and breadth of any such future cooperation, however, will be very difficult to predict at the time of writing, as is indeed the question of Brexit itself.