With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory Agency (MHRA) have recently published guidelines relating to new rules relating to, amongst other things, medical devices and medicines, which need to be complied with from 1 January 2021. In this note, we unpack some of the main points included in the guidance relating to medical devices.
During early September 2020, the MHRA published a variety of guidelines on its website (accessible here), which shed some light on the post-transition regulation of a variety of topics in the UK, such as 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 while the underlying legislation is still subject to parliamentary approval.
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 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 sometime 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, 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 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. 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. 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.