This article was co-authored by Natalie Man, Litigation Assistant, London.
Since the UK’s exit from the European Union (EU), the Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on the regulation of medical devices and the requirements for their entry into the UK market.
The MHRA’s most recent guidance forms part of an updated version published in December 2020 following changes to the regulatory landscape resulting from Brexit.
Whilst some, but not all, of the transition requirements are now obsolete, the primary aim of this updated guidance is to reflect the changes to medical device registration and regulatory requirements taking effect on 1 January 2022 under the Medical Devices Regulations 2002 (SI 2002/618, as amended) (the 2002 Regulations).
Manufacturers, suppliers and importers of medical devices must take note of these important changes. It is important to note that the guidance sets out the different rules that apply in Great Britain and Northern Ireland in accordance with the Northern Ireland Protocol.
Updated guidance on registration of medical devices in Great Britain (GB)
- Registration requirements apply to all medical devices, including in vitro medical devices (IVDs), active implantable medical devices as well as custom-made devices, systems and procedure packs.
- References to the pre-existing post-Brexit deadlines and grace periods for registration have been removed.
- Accounts of former GB-based Authorised Representatives who have failed to update their role to UK Responsible Person on the MHRA registration system, as well as accounts of any represented manufacturers are suspended from 1 January 2022 until the relevant UK Responsible Person has updated their role. The UK Responsible Person will then assume responsibilities of the manufacturer in terms of registering the device with the MHRA.
- Distributors and suppliers are not required to register with the MHRA.
- Where the GB importer is not the UK Responsible Person, the importer must inform the relevant manufacturer or UK Responsible Person of their intention to import a device. In these circumstances, the manufacturer or UK Responsible person must provide details of the importer to the MHRA.
Updated guidance on the registration of medical devices in Northern Ireland (NI)
Guidance on the placing of medical devices on the NI market is provided for non-UK manufacturers as well as GB-based manufacturers. Guidance is also provided on registration of importers and custom-made devices.
- May be required to appoint a single UK Responsible Person within the UK for certain classifications of IVD products placed on the NI market. A UK Responsible Person is not required on order to place IVD that do not fall within those device classifications on the NI market.
- Are not required to appoint a UK Responsible Person to place general medical devices and active implantable medical devices on the NI market.
When placing an IVD on the NI market, a UK Responsible Person is required to be appointed if certain criteria are fulfilled e.g. the manufacturer is based in the EU or European Economic Area (EEA). The UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.
GB-based manufacturers must designate an Authorised Representative based in the EU or NI in order to place a device on the NI market:
- Where an EU-based Authorised Representative is appointed, the GB-based manufacturer must register all device classes other than Class I devices and general IVDs with the MHRA.
- Where a NI-based Authorised Representative is appointed, the Authorised Representative must register all devices with the MHRA.
Distributors and suppliers are not required to register with the MHRA.
A NI-based Authorised Representative or UK Responsible Person must provide the MHRA with details of the person placing the product on the NI market if that person is not the manufacturers, the NI-based Authorised Representative or the UK Responsible Person (for IVDs only).
In accordance with The Medical Devices (Northern Ireland Protocol) Regulations 2021, all custom-made devices must be registered with the MHRA within 28 days of being made available on the NI market.
Non-UK manufacturers will require a UK Responsible Person for the purposes of registering devices placed on the GB market. A NI-based Authorised Representative will no longer be permitted to register devices on a manufacturers behalf for the GB market.
2021 registration deadlines and time requirements to register devices have been updated to remove references to pre-existing grace.
Registration can be made via the Device Online Registration System (DORS). The MHRA may request additional technical information before a product's registration on the DORS is confirmed.
New guidance on the regulation of medical devices in the UK
- All references to the pre-existing 2021 deadlines for registration and grace periods have been removed.
- Advice on registrations in GB have been revised in order to reflect the expiry of 2021 registration deadlines.
- Advice concerning the appointment of the UK Responsible Person in both the GB and NI markets have been updated to reflect the mandatory nature of this requirement.
- Points of requirements for placing a device on the NI market have been modified in order to conform to the NI protocol requirements.
- Discussion about the current position of UK-based manufacturers faced with completing another complex process in order to place their devices on the EU market. These obligations have been amended to reflect the non-recognition of the UK medical device regulatory regime in the EU, including regarding conformity assessments.
The new EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Medical Devices Regulation (EU IVDR) did not take effect during the Brexit transition period, as expected, due to delays arising from COVID-19. As a result, medical devices in the UK continue to be regulated under the 2002 Regulations, which give effect to the previous EU framework comprising EU directives 93/42/EEC and 98/79/EC for medical devices and IVDs, respectively.
On 11 February 2021, the Medicines and Medical Devices Act came into force, empowering the Secretary of State to amend the existing regulatory framework, to include that which governs medical devices in the UK. It is expected that the future regulatory framework will align with the EU MDR and the EU IVDR.
In the interim, medical devices marked with the EU’s CE mark can be used until June 2023. All medical devices sold in the UK thereafter will need to be reviewed by the UK’s authoritative bodies and given a UK Conformity Assessment marking (UKCA).
Since there is currently no mutual recognition of conformity assessments between the EU and the UK, UK manufacturers selling on both markets will need to go through the testing process twice. The costs and complexities of putting their devices through the UKCA process, in addition to the updated EU process, may deter some companies based outside of GB from marketing their medical devices on the UK market.