On 26 May 2021, the UK’s medical device laws will diverge from EU law. This is the end of the transition period for the EU Medical Device Regulations (EU MDR) in the EU and sees the full application of the EU MDR across all member states. Subsequently on 26 May 2022, the EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), will apply fully in EU member states, but again will not apply in Great Britain, creating further divergence in medical device regulatory requirements.
The UK’s regime for medical devices will continue to be based on the current EU Medical Devices Directives implemented in the UK by the Medical Devices Regulations 2002 (MDR 2002), which have been amended to reflect the UK’s new post-Brexit regulatory regime. In particular, the MDR 2002, as amended, does not include any of the revisions that would have been made by the EU MDR. It also clarifies how devices will be regulated in Northern Ireland under the NI Protocol and provides that devices placed on the market there will be required to continue to comply with EU medical devices legislation.
In practical terms, this means that manufacturers that have not obtained CE marking for medical devices under the requirements of the EU MDR (or the EU IVDR), will still be able to sell and market their devices in Great Britain (but not Northern Ireland) if they meet the 2002 Regulations (as amended). Given some of the changes imposed under the EU MDR, which require a large number of devices to be reclassified from Class I to Class IIa (and the associated additional regulatory requirements), this may be a welcome divergence for some manufacturers especially of software which is classified as a medical device.
Any future changes in the UK regulations will be enabled through the powers granted in the new Medicines and Medical Devices Act 2021 which supplements the MDR 2002 (as amended) and provides the regulatory framework for medical devices and medicines in the UK post Brexit.
In the future, for manufacture and supply of medical devices in the UK, Medicines and Healthcare products Regulatory Agency (MHRA) registration is required. However, if a medical device was already registered with the MHRA before 1 January 2021, there is no requirement for re-registration, but there is a requirement to ensure the information held by the MHRA remains compliant. There is a new requirement for manufacturers based outside of the UK to assign a UK Responsible Person to register and act on their behalf.
Comfort for manufacturers comes in the form of a grace period depending upon the nature of the medical device, which will allow time for compliance with the amended registration process. Examples of this are as follows:
The new product mark to be used for medical devices placed on the market in Great Britain is the UKCA mark. CE marking will be recognised here until 30 June 2023. Thereafter, a UKCA mark will be necessary for a device to be marketed in Great Britain. A CE mark will continue to be needed for devices placed on the market in Northern Ireland. It is imperative that those wishing to place devices on the UK market review the MHRA guidance to ensure they are fully compliant post transition.
Perhaps the most controversial element of the Act is the wide range of powers granted directly to the Secretary of State for Health to amend the existing regulatory framework. To combat these concerns, the House of Lords introduced changes including the new role of an Independent Commissioner for Public Safety with a principal aim of safeguarding public health, public consultations relating to proposed regulations and requirements for the MHRA to put forward periodic reports before Parliament.
The Act introduces new enforcement powers to the MHRA, that allow it to impose either civil or criminal sanctions for breaches of the Act or any secondary legislation made under it, enabling both corporates and individuals to be held liable, including company directors.
The MHRA must now draft and publish guidance regarding the civil sanctions that can be imposed, which should provide clarity on the monetary penalties and the MHRA’s power to accept enforcement undertakings in the place of criminal conviction or the issuing of a fine. Given that so much focus has been given to safeguarding public health and safety, we expect to see rather crushing financial sanctions where corporate entities have not implemented robust health and safety procedures.
The Act aims to create a structure for the UK Government to legislate for amendments to existing laws on human (and veterinary) medicine, clinical trials, and medical devices. As the Brexit transition period has come to an end, this will be key in ensuring that the UK continues to be a leader in the life sciences industry, taking advantage of new medicines and technologies as quickly as possible as it is able to utilise the world leading expertise of the MHRA as well as making legislative changes swiftly through secondary legislation.
As the Act now provides the UK with the flexibility to respond quickly to medical advances and developments in medical technology, the Government states that it will be invaluable to the UK creating its own regulatory landscape, with the powers the Act allows enabling it to either change with the EU going forward, or on the contrary, branch off onto a path of its own. Thus, it will be interesting to see how the Government and the MHRA strike a balance with the evolving regulatory regime. It is notable that the UK-EU Trade and Cooperation Agreement had no provision for the mutual recognition of regulatory regimes, so divergence was almost inevitable.
The pandemic and the speed and efficiency of vaccine approvals have most definitely shown the MHRA in a positive light, and the UK continues to be an important market for medicines and medical devices. With the flexibility outlined above, we can look forward to seeing the new regulatory regime roll out and will watch with interest the impact and extent of the divergence from the EU’s regime.
This article has been co-written with Grace Lymer-Sullivan, a trainee solicitor in the commercial, IP and IT team.