Brexit: Medical devices implications

By Sally Shorthose

01-2021

The UK exited the EU on 31st January 2020. The transition period in the Withdrawal Agreement ended on 31st December 2020. Existing EU Treaties, EU free movement rights and the general principles of EU law now no longer apply in relation to the UK. EU regulations only continue to apply in UK domestic law (by virtue of the European Union (Withdrawal) Act 2018) to the extent that they are not modified or revoked by regulations under that Act.

The EU and the UK negotiating teams have agreed the terms of a detailed post-Brexit Trade and Cooperation Agreement which has been given effect from 1st January 2021 (the “TCA”).

This article sets out the implications of Brexit on the UK medical devices industry now that the transition period has come to an end. 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 applied in relation to the UK until 31 December 2020, during the so called transition period, the status quo was maintained as much as possible. However, plans need to be made immediately, to the extent they are not already underway, for the significant changes that have now occurred.

Medical devices are dealt with in chapter (4) (under Trade – Title I) of the TCA. While there is some move towards the elimination of unnecessary technical barriers to trade and the conformity of standards, the TCA only provides that the UK and the EU:

- can agree that its standards bodies (including those relating to medical devices) will conform with international standards;

- will work together to influence those standards; and

- will “foster bilateral cooperation with the standardising bodies of the other Party”.

Whilst many commentators had hoped that some form of mutual recognition of standards might emerge, the UK government has indicated that this is not what they will be seeking. The EU has given no indication that the UK will be treated other than as a third country like any other. It has also not even been agreed that there will be a mutual recognition of conformity assessments under which each of the EU and the UK would recognise the other’s certification bodies. Great Britain (but not Northern Ireland) will continue to accept CE marked medical devices until 30 June 2023 but those devices certified by the UK and marked as UKCA (standing for ‘UK Conformity Assessed’, as discussed in more detail in our post here), will not be mutually recognised by the EU (more detail is provided below).

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 as a contact for the authorities. Quality management and safety officers will be required to ensure compliance under the Medical Devices Regulations 2019.

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (UK MDR 2019) amended UK legislation to reflect the new regime for the UK’s departure from the EU, and transposed all the key elements in EU legislation (i.e. the UK will be bound by the revised Regulations until 2022 at least, along with the transitional timetable established for that legislation).

During early September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published a variety of guidelines on its website (accessible here). These guidelines need to be complied with from 1 January 2021. The guidelines shed some light on the post-transition regulation of a variety of topics in the UK. For example, clinical trials, medical devices, licensing, importing and exporting of medical devices, active substances and medicines, IT systems and pharmacovigilance matters. These guidelines are subject to change, and were amended regularly throughout the latter stages of 2020, while the underlying legislation is still subject to parliamentary approval (please see next paragraph). Below, we unpack some of the main points included in the guidance relating to medical devices.

Changes to the rules?

The key legislation applicable to medical devices in Great Britain will still be the Medical Devices Regulations 2002 (SI 2002 No 618), as amended and in the form in which they exist on 1 January 2021 (UK MDR 2002). The UK MDR 2002 does not currently include any of the amendments that would have been made by the new EU Medical Devices Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), which only come into force in the EU after 1 January 2021. Accordingly, the EU MDR and EU IVDR shall not automatically apply in Great Britain. Instead, the Medicines and Medical Devices Bill, which is currently going through Parliament [1], is intended to supplement the UK MDR 2002.

The new rules relating to medical devices are relatively complex and nuanced depending on the circumstances (see further here). Please also note that the rules differ quite substantially between Great Britain and Northern Ireland. This having been said, the key aspects to consider at this stage, which apply from 1 January 2021, include the following:

  • Manufacturers wishing to place a medical device on the UK market must first register with the MHRA. Non-UK based manufacturers will, in most cases, need to designate a UK Responsible Person to register and act on its behalf.

  • Depending on the nature of the medical device, there are three categories of grace periods that apply to allow time for compliance with the new registration process. For example, active implantable medical devices must be registered by 30 April 2021, while Class I medical devices must generally be registered with the MHRA by 31 December 2021.

  • The UKCA mark is the new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market. For detailed guidance relating to the use of this mark, see here. Here are some of the essential points regarding UKCA and CE marks:

    • With regard to transitional arrangements, CE marking may continue to be used in Great Britain and will be recognised by the MHRA until 30 June 2023. From 1 July 2023, a UKCA mark will be required in order to place a device on the Great Britain market. In addition, certificates issued by EEA-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023. Even where mandatory Notified Body conformance assessment is required in respect of certain devices, these transitional arrangements may be relied upon.
    • The UKCA mark will not be recognised in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE mark for sale in these markets (or a UK(NI) Mark for Northern Ireland). The UKCA mark will be mandatory from 1 January 2021 for devices placed on the Great Britain market, in circumstances where, for example, the product is governed by legislation which requires the UKCA marking or it requires mandatory third-party conformity assessment.
    • Please note that from 1 July 2023, a CE mark will continue to be needed for devices placed on the Northern Ireland market.

From a practical perspective, the above changes may present some challenges to device manufacturers and other entities wishing to place devices on the UK market after 1 January 2021. They are encouraged to review the MHRA guidance and to ensure that their businesses are ready for a post-transition Brexit UK.

Please do not hesitate to contact us should you require any assistance with making sense of the MHRA guidance and how it applies to your business.

This article is part of our Brexit series


[1] Currently in HoL, was due to go to Report Stage on 12 Jan 2021 https://services.parliament.uk/bills/2019-21/medicinesandmedicaldevices.html

 
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