Medical devices import UK — MHRA registration and UKCA marking

UKCA vs CE — differences for medical devices after Brexit

Since 1 January 2021 the United Kingdom has not been part of the EU single market, and the medical devices market in GB (England, Scotland and Wales) is subject to separate rules. The key change: CE marking, required under Directive 93/42/EEC and EU MDR 2017/745, has been replaced by UKCA (UK Conformity Assessed) marking on the GB market. UKCA marking is recognised exclusively in GB — it is not accepted in the EU. Equally, CE marking is no longer sufficient (once the transitional periods have expired) to place a device on the GB market.

The legal basis in the UK is the Medical Devices Regulations 2002 (UK MDR 2002) as amended post-Brexit. The MHRA (Medicines and Healthcare products Regulatory Agency) is the sole regulator responsible for overseeing medical devices in GB. Northern Ireland (NI) is an exception: under the Windsor Framework (the successor protocol to the NI Protocol), medical devices placed on the NI market remain subject to EU regulatory requirements (MDR/IVDR) rather than UK MDR 2002. This means that CE and UKNI marking are accepted in NI.

Key differences between UKCA and CE for medical devices

The principal differences between UKCA and CE marking from a medical device manufacturer's perspective:

• Conformity assessment body: UKCA requires assessment by a UK Approved Body (UKAB) — a UK-accredited body; CE requires assessment by a Notified Body accredited in an EU member state.
• Geographic scope: UKCA applies only in England, Scotland and Wales (GB); CE applies in EU/EEA countries and in Northern Ireland.
• UK Responsible Person: non-UK manufacturers must have a UK RP whose details appear on the label; the equivalent role in the EU is the Authorised Representative (EC REP).
• Registration: MHRA requires the device to be registered via its online portal before being placed on the GB market; in the EU, registration is done through EUDAMED.
• Legal basis: UKCA — UK MDR 2002 (as amended); CE — EU MDR 2017/745 or IVDR 2017/746.

Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

Northern Ireland — special status under the Windsor Framework

Northern Ireland has a distinct regulatory status for medical devices. Under the Windsor Framework (the successor to the NI Protocol), medical devices placed on the NI market are subject to EU rules (MDR/IVDR) rather than UK MDR 2002. This means that CE or UKNI marking (a special marking for NI) is accepted in NI. Manufacturers supplying devices exclusively to NI do not need to obtain UKCA marking. However, companies wishing to sell in both GB and NI must ensure compliance with both regulatory systems — or use the appropriate marking depending on the target market.

Medical device classes in the UK and requirements for each class

UK MDR 2002 (as amended) establishes a risk-based device classification system analogous to the EU system. The medical device classes in the UK are: Class I (lowest risk), Class IIa, Class IIb and Class III (highest risk). In vitro diagnostic devices (IVDs) are subject to a separate classification system discussed later in this article.

Class I — low-risk devices

Class I includes medical devices with the lowest risk profile, such as plasters, certain bandages, stethoscopes and corrective spectacles. Requirements for Class I:

• Registration with the MHRA (via the online portal) before the device is placed on the GB market.
• Declaration of Conformity issued by the manufacturer — no UK Approved Body (UKAB) involvement required for non-sterile, non-measuring Class I devices.
• Class I devices that are sterile or have a measuring function require UKAB involvement for those specific aspects.
• UK Responsible Person (UK RP) — mandatory for non-UK manufacturers.
• UKCA marking on the device and packaging (once the transitional period has expired).

Class IIa and IIb — medium-risk devices

Class IIa covers devices such as hearing aids, single-use contact lenses and certain implants. Class IIb covers higher-risk devices such as ventilators, infusion pumps and devices intended for long-term implantation (other than Class III). Requirements for Classes IIa and IIb:

• Involvement of a UK Approved Body (UKAB) — a UK-accredited notified body — for assessment of the quality management system or technical documentation.
• Registration with the MHRA before the device is placed on the GB market.
• Declaration of Conformity referencing UK MDR 2002.
• UK Responsible Person's details on the device label.
• UKCA marking.

Class III — highest-risk devices

Class III covers medical devices with the highest risk: cardiac implants, heart valves, coronary stents and brain implants. Requirements for Class III:

• Full conformity assessment by a UK Approved Body (UKAB) — mandatory.
• Clinical investigations conducted in accordance with UK MDR 2002 (as amended), or recognition of clinical data from existing studies.
• MHRA registration with full clinical documentation.
• UK Responsible Person's details on the label.
• UKCA marking.
• The conformity assessment procedure is the most rigorous — obtaining UKCA for a Class III device can take from several months to over a year.

Full list of classes and classification criteria: gov.uk/guidance/regulating-medical-devices-in-the-uk.

MHRA registration — how to register a medical device in the UK

Every manufacturer or UK Responsible Person placing a medical device on the GB market must register the device with the MHRA before its first supply. Registration is carried out via the MHRA online portal (Device Registration). Failure to register constitutes a breach of UK MDR 2002 and may result in the suspension of market placement and administrative sanctions. The import documentation requirements for medical devices are closely linked to the MHRA registration requirements.

Step by step — the MHRA registration procedure

The procedure for registering a medical device with the MHRA:

1. Create an account on the MHRA Device Registration portal — the account is set up by the manufacturer or UK RP. An email address and contact details are required.
2. Prepare the technical documentation — including the declaration of conformity with UK MDR 2002, device description, classification, clinical data (for Classes IIa, IIb and III) and information about the UK Approved Body (if involved).
3. Assign a GMDN code (Global Medical Device Nomenclature) — the MHRA requires a GMDN code to be assigned to every device registered on the portal.
4. Complete the registration form on the portal — device data, class, description, manufacturer details and UK RP details.
5. Pay the registration fee — the MHRA charges fees for registration; the amount depends on the device class and type of registration (new vs. amendment). Check current fee rates on gov.uk.
6. Registration confirmation — the MHRA reviews the submission and assigns a registration number. For higher-risk classes, the review period may be longer.

Important: MHRA registration must be updated when there are material changes to the device, manufacturer details or UK RP. Before beginning to import medical devices into the UK, make sure you also have an EORI number for UK imports.

Documentation required for registration

Technical documentation required for MHRA registration (scope depends on device class):

• UK Declaration of Conformity referencing UK MDR 2002.
• Device description and specification — materials, dimensions, intended clinical purpose.
• Clinical Evaluation Report — required for Classes IIa, IIb and III.
• UK Approved Body certificate — for Classes IIa, IIb and III.
• Instructions for Use (IFU) in English.
• Device label containing the UK RP's details.
• Post-Market Surveillance plan.

Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

UK Responsible Person — who they are and why they are required

The UK Responsible Person (UK RP) is an institution specific to the GB market, introduced after Brexit for manufacturers based outside the United Kingdom. UK MDR 2002 requires that every non-UK manufacturer appoints a UK RP as their official representative in Great Britain. The UK RP is a UK-registered entity that bears legal responsibility for the device's compliance with UK MDR 2002 in its dealings with the MHRA.

Duties of the UK Responsible Person

The UK RP carries out the following functions under UK MDR 2002:

• Registering the medical device with the MHRA on behalf of the manufacturer.
• Acting as the point of contact with the MHRA on regulatory matters, inspections and device safety.
• Maintaining technical documentation and the declaration of conformity (or ensuring the MHRA has access to them).
• Reporting incidents and Field Safety Corrective Actions (FSCAs) to the MHRA.
• Ensuring the device bears UKCA marking and a label with the UK RP's details before it is placed on the GB market.

Note: the UK RP's details must appear directly on the medical device label or packaging — this is not an optional requirement. Absence of UK RP details on the label constitutes non-compliance with UK MDR 2002.

How to find a UK Responsible Person — options for Polish manufacturers

Polish medical device manufacturers planning to export to the UK have several options for appointing a UK RP:

1. Own UK subsidiary or branch — if the manufacturer has a legal entity established in the UK, that entity can act as the UK RP.
2. Specialist UK RP company — there are companies in the UK market that provide commercial UK RP services for foreign medical device manufacturers. A UK RP agreement is a standard regulatory document.
3. UK distributor — if a UK distributor meets the requirements of UK MDR 2002 and agrees to do so, they may act as the UK RP.

The cost of a UK RP service ranges from a few hundred to a few thousand pounds per year, depending on the number of devices and risk class. It is worth factoring this cost into the calculation of customs duty and VAT on imports to the UK. For regular shipments of medical devices to the UK, it is also worth considering AEO status for UK importers — it can simplify customs clearance.

Transitional arrangements — until when is CE accepted in the UK?

After Brexit, the MHRA and the UK government introduced several extensions to the transitional periods during which CE marking was temporarily accepted on the GB market. This was due to difficulties in obtaining UKCA certificates from UK Approved Bodies and the time needed for manufacturers to adapt. The following is based on information available on gov.uk — given the history of repeated extensions, always check the latest MHRA guidance.

CE acceptance timetable for GB — key dates

History and current status of the CE marking transitional arrangements for GB (England, Scotland and Wales):

• 1 January 2021: Brexit — GB leaves the CE system; transitional periods introduced.
• Until 30 June 2023: original end of the transitional period (for most medical devices).
• Extensions 2023–2024: the UK government extended CE acceptance on several occasions due to limited capacity at UK Approved Bodies.
• Until 30 June 2025: CE marking accepted in GB for most medical devices covered by UK MDR 2002 (based on current gov.uk guidance).
• From July 2025: UKCA marking required for most medical devices placed on the GB market.

Important caveat: the timetable has been amended multiple times by the MHRA. Before making any business decisions, always check the latest guidance at gov.uk/guidance/regulating-medical-devices-in-the-uk.

Devices and situations with separate transitional arrangements

Certain device categories or situations may be subject to different transitional deadlines:

• Custom-made devices: subject to separate UK MDR 2002 provisions — a separate conformity procedure without the obligation to obtain a UKAB certificate.
• Devices used in clinical investigations: devices used exclusively in MHRA-registered clinical investigations are subject to separate provisions.
• Devices already placed on the market before the deadline: CE-marked devices lawfully placed on the GB market before the end of the transitional period may remain on the market until the end of their shelf life or useful life.
• Northern Ireland: CE and UKNI marking are accepted indefinitely under the Windsor Framework.

Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

IVDs — in vitro diagnostic devices — separate rules

In vitro diagnostic devices (IVDs) are a separate category regulated in the UK by UK MDR 2002 (Part IV, implementing Directive 98/79/EC on IVDs and subsequent amendments). IVDs include diagnostic tests, laboratory reagents and self-test kits (e.g. pregnancy tests, blood glucose monitors, antigen tests). The IVD classification system in the UK differs from that used for general medical devices.

IVD classification in the UK

UK MDR 2002 for IVDs uses the following classification:

• List A (formerly Annex II List A): highest-risk IVDs — including HIV tests, tuberculosis tests and blood-typing tests (ABO, Rhesus). Require UK Approved Body involvement.
• List B (formerly Annex II List B): high-risk IVDs — including rubella tests, toxoplasmosis tests and self-testing blood glucose monitors. Some require UKAB involvement.
• Other IVDs: the majority of lower-risk diagnostic tests — manufacturer self-certification, MHRA registration.

Note: the MHRA is working on a new risk-based IVD classification system aligned with the EU IVDR 2017/746 approach. Check gov.uk for updates, as new regulations may alter IVD requirements.

Additional requirements for IVDs placed on the GB market

Requirements specific to IVDs on the GB market:

• MHRA registration (Device Registration portal) — mandatory before placing the device on the market.
• UK Responsible Person — mandatory for non-UK manufacturers, as for general medical devices.
• UKCA marking (once the CE transitional period has expired).
• For self-test IVDs: additional requirements regarding English-language instructions and the presentation of results.
• Performance studies (the IVD equivalent of clinical investigations) — regulated by UK MDR 2002 (as amended) and require MHRA notification.

Source: gov.uk/guidance/regulating-medical-devices-in-the-uk. Full customs handling for medical device imports to the UK is available through Easy Clearance.

What the current official rules require

Importing medical devices into GB (England, Scotland and Wales) after Brexit requires meeting the following key requirements: (1) UKCA marking instead of CE (from July 2025 for most devices); (2) MHRA registration via the online portal before the device is placed on the market; (3) appointment of a UK Responsible Person by non-UK manufacturers; (4) involvement of a UK Approved Body for Classes IIa, IIb and III. Northern Ireland continues to accept CE and UKNI marking under the Windsor Framework. IVDs are subject to a separate classification system and rules. This article reflects the legal position as at 2026-06-06 — check for updates at gov.uk/guidance/regulating-medical-devices-in-the-uk, as the MHRA regularly updates its guidance on transitional deadlines.

FAQ — frequently asked questions

Can medical devices bearing CE marking be imported into the UK after Brexit?

After Brexit, GB (England, Scotland and Wales) requires UKCA marking instead of CE. CE marking was accepted in GB under transitional arrangements until the end of June 2025 (with certain exceptions). From July 2025 most medical devices placed on the GB market require UKCA or UKCA+UKNI marking. Exception: Northern Ireland (NI) continues to accept CE and UKNI marking under the Windsor Framework. Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

What is a UK Responsible Person and does every medical device importer need one?

A UK Responsible Person (UK RP) is a UK-based entity appointed by a non-UK manufacturer that takes legal responsibility for compliance with UK MDR 2002 and for registrations with the MHRA. The UK RP is not the same as an importer — an importer is the party that physically brings goods into the UK, whereas the UK RP acts as the manufacturer's official representative in the UK. Non-UK manufacturers (e.g. Polish companies) wishing to sell medical devices on the GB market must appoint a UK RP. Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

How do I register a medical device with the MHRA?

Medical device registration with the MHRA is carried out via the MHRA Device Registration online portal. The manufacturer or UK Responsible Person must create an account on the portal, enter the device details (class, description, GMDN codes), upload the required documents (declaration of conformity, technical documentation) and pay the registration fee. Registration must be completed before the device is placed on the GB market. Classes IIa, IIb and III require submission to an accredited UK Approved Body (UKAB). Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

How does UKCA differ from CE for medical devices?

UKCA (UK Conformity Assessed) is the UK equivalent of the CE mark, valid exclusively for the GB market. Key differences: (1) UKCA is issued by accredited UK Approved Bodies (UKABs) rather than EU Notified Bodies; (2) UKCA applies only in England, Scotland and Wales — it is not recognised in the EU; (3) the UKCA declaration of conformity references UK MDR 2002 (as amended), not the EU MDR/IVDR; (4) non-UK manufacturers must have a UK Responsible Person whose details appear on the device label. Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

Until when is CE marking accepted for medical devices in the UK?

CE marking was accepted in GB (England, Scotland and Wales) under transitional arrangements that were extended on several occasions. According to current gov.uk guidance, the transitional period for CE acceptance in GB for most medical devices expired at the end of June 2025, and from July 2025 UKCA marking is required. In Northern Ireland, CE marking continues to be accepted indefinitely under the Windsor Framework. Always check the latest MHRA guidance on gov.uk — deadlines may have changed. Source: gov.uk/guidance/regulating-medical-devices-in-the-uk.

Official sources

• Regulating medical devices in the UK — gov.uk MHRA — GOV.UK
• Medicines and Healthcare products Regulatory Agency (MHRA) — gov.uk — GOV.UK