The short version: With the UK's withdrawal from the EU, the Medicines and Healthcare products Regulatory Agency (MHRA) now runs its own medical device regime. Manufacturers based outside the UK must appoint a UK Responsible Person, register devices with the MHRA on a staggered timeline, and eventually move from CE marking to the UKCA mark for Great Britain. Northern Ireland keeps the EU MDR/IVDR CE mark, with a UK(NI) mark layered on when a UK Notified Body performs the conformity assessment.
The MHRA will only accept device registrations from companies based in the UK, a company's UK Responsible Person, or from an Authorized Representative based in Northern Ireland.
Among the many issues facing the device industry, the start of 2021 also brought the official withdrawal of the United Kingdom from the European Union (Brexit). As part of that, the UK will (again) develop and implement its own regulations of medical devices. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has established transition and implementation timelines for devices being placed onto the UK market.
In keeping with all things Brexit, there are many nuanced implementation issues depending on whether you are placing a device on the Great Britain market (England, Scotland, and Wales) or Northern Ireland market. Note that the Republic of Ireland (Ireland) is still part of the EU, and the EU directives and regulations still apply.
What the MHRA Has Stated
Specifically, the MHRA has stated:
- Device manufacturers based outside of the UK must establish a UK Responsible Person (UKRP) who will be responsible for the product in the UK.
- Until 1 July 2023, the MHRA will continue to recognize existing European CE marking (compliance to EU Medical Device Directives [MDD, AIMD, IVDD], the Medical Devices Regulation [MDR] and the In Vitro Diagnostic Regulation [IVDR]).
- For any device placed on the Great Britain market after that, manufacturers will need to obtain a UK Conformity Assessment (UKCA) mark to be legally marketed in England, Scotland, and Wales.
- In Northern Ireland, the EU MDR/IVDR CE mark is required. In addition, a UK(NI) mark is required if a UK Notified Body performs the third-party conformity assessment. Great Britain-based manufacturers must also have an EU or Northern Ireland-based Authorized Representative to place devices on the Northern Ireland market. Note that devices placed only on the Northern Ireland market must also be registered with the MHRA.
- As with the directives, Class I devices with a measuring function or that are sterile require approval from a UK Approved Body.
Why the Responsible Person matters: For manufacturers based outside the UK, the UK Responsible Person is the legal anchor for the product in the British market. Choosing and onboarding that party early is what keeps registrations from slipping past the MHRA deadlines below.
MHRA Registration Requirements and Deadlines
On 31 December 2020, the MHRA published new guidance on the registration requirements and deadlines for medical devices and IVDs currently being placed on the UK market, which took effect on 1 January 2021. Even ahead of the transition to UK national conformity, any medical device being placed on the UK market (including Northern Ireland) must be registered with the MHRA according to the following implementation timeline. Note also that these are the deadlines by which a manufacturer based outside of the UK must appoint a UK Responsible Person.
1 January 2021 — Where the manufacturer is in the UK or the Authorized Representative is in Northern Ireland (current requirements):
- Class I devices
- Custom-made devices
- General IVDs
1 May 2021:
- Active implantable medical devices
- Class III medical devices
- Class IIb implantable medical devices
- IVD List A products (Annex II)
1 September 2021:
- Class IIb non-implantable medical devices
- Class IIa medical devices
- IVD List B products
- Self-test IVDs
1 January 2022 (for those manufacturers or Authorized Representatives not based in the UK):
- Class I medical devices
- General IVDs
The MHRA will only accept device registrations from companies based in the UK, a company's UK Responsible Person, or from an Authorized Representative based in Northern Ireland. Note that there is a fee for each registration, including updating information on an existing registration, and the GMDN is a mandatory field.
From design to post market, managing change to a medical device is critical — and Brexit added an entirely new conformity pathway to manage alongside the EU one.
Building Compliance That Holds Up Across Both Markets
The dual-track reality — UKCA for Great Britain, CE plus a possible UK(NI) mark for Northern Ireland — means quality and registration data has to be accurate, traceable, and audit-ready in more than one regime at once. Strong data integrity practices keep your device registrations, technical files, and post-market records defensible no matter which authority asks. Where validation and qualification work supports your submissions, a disciplined computer software assurance (CSA) approach helps you focus effort on the systems that carry the most patient and compliance risk.
How USDM Helps Medical Device Manufacturers
From design to post market, managing change to a medical device is critical. Our Medical Device division helps customers bring their products to market faster, monitor their products in the field, and handle post-market surveillance while addressing a variety of regulatory challenges unique to the medical device industry.
USDM offers comprehensive services to help navigate a complex regulatory landscape, including compliance and quality strategy and execution, audits and assessments, remediation, validation lifecycle management, global product identification and much more. For organizations carrying a heavy validation footprint across systems and markets, USDM Cloud Assurance keeps validated environments continuously compliant as regulations and vendors evolve.
FAQ: Medical Device Implications of Brexit
Who can register a medical device with the MHRA after Brexit?
The MHRA will only accept device registrations from companies based in the UK, a company's UK Responsible Person, or from an Authorized Representative based in Northern Ireland. Manufacturers based outside the UK must establish a UK Responsible Person (UKRP) to act on their behalf.
How long is CE marking still recognized in the UK?
Until 1 July 2023, the MHRA will continue to recognize existing European CE marking, including compliance with the EU Medical Device Directives (MDD, AIMD, IVDD), the Medical Devices Regulation (MDR), and the In Vitro Diagnostic Regulation (IVDR). After that point, devices placed on the Great Britain market need a UK Conformity Assessment (UKCA) mark.
What's different about placing a device on the Northern Ireland market?
In Northern Ireland, the EU MDR/IVDR CE mark is required. A UK(NI) mark is additionally required if a UK Notified Body performs the third-party conformity assessment. Great Britain-based manufacturers must also have an EU or Northern Ireland-based Authorized Representative, and devices placed only on the Northern Ireland market must be registered with the MHRA.
When did MHRA registration deadlines take effect?
The MHRA published new registration guidance on 31 December 2020, which took effect on 1 January 2021. Devices are then registered on a staggered timeline through 1 May 2021, 1 September 2021, and 1 January 2022 depending on device class and where the manufacturer or Authorized Representative is based.
Is there a cost to register a device with the MHRA?
Yes. There is a fee for each registration, including for updating information on an existing registration, and the GMDN (Global Medical Device Nomenclature) is a mandatory field.
Navigate the UK Transition With Confidence
Mapping every device in your portfolio to the right UK pathway — and hitting each MHRA deadline — is exactly the kind of work where experienced regulatory and quality support pays off. Contact USDM Life Sciences to plan your UKCA, UK(NI), and MHRA registration strategy.
About the Author
Jay Crowley is the Vice President of Unique Device Identification Solutions at USDM Life Sciences. He is a recognized expert in the area of UDI and held a variety of positions over his 26 years at the FDA, including developing the requirements for the FDA's UDI System. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.