Compliance Checklist

CE Marking
Health & Medical
United Kingdom 🇬🇧

Medical device compliance for Great Britain: UK Medical Devices Regulations 2002, MHRA registration, CE transitional deadlines until 2028/2030 and common mistakes.

Overview

Medical devices in Great Britain (England, Scotland, Wales) are no longer governed by the EU MDR since Brexit but by the UK Medical Devices Regulations 2002 (SI 2002/618, amended several times), overseen by the MHRA (Medicines and Healthcare products Regulatory Agency) instead of Germany's BfArM. The mandatory UKCA marking originally planned for 2023 has been postponed repeatedly: CE-marked products under the old MDD/AIMDD are currently accepted until 30 June 2028, products under EU MDR/IVDR until 30 June 2030. From February to 10 April 2026, the MHRA ran a consultation proposing to extend the MDD/AIMDD deadline to 31 December 2028 and to grant indefinite recognition to MDR/IVDR-marked CE devices (removing the 2030 sunset date) – the outcome was still pending at the time this checklist was written. Regardless of CE or UKCA, registration with the MHRA via the Device Online Registration System (DORS) is mandatory for all classes. Northern Ireland continues to follow the EU MDR with CE marking (Windsor Framework).

Does this apply to my product?

This checklist applies to all medical devices sold to consumers in Great Britain via Amazon.co.uk: blood pressure monitors, fever thermometers, blood glucose meters, pulse oximeters, wound care products, orthopedic aids, compression stockings, hearing aids and in vitro diagnostics such as pregnancy or self-tests. As in the EU: only products with a medical intended purpose fall under this regulation – pure wellness products without a treatment or diagnostic claim instead fall under the Electrical Equipment (Safety) Regulations 2016 and the Electromagnetic Compatibility Regulations 2016.

Step-by-Step Guide

Progress0/9 (0%)

Determine legal framework and transitional deadlines

First clarify which CE certification pathway your product falls under (MDD/AIMDD or MDR/IVDR) – this determines how long it can continue to be sold in the GB market without UKCA.

Estimated time: 1 week

CE certification basis identified (MDD/AIMDD vs. MDR/IVDR)Required

Check your EU Declaration of Conformity to see whether the product is still certified under the old Medical Device Directive (MDD 93/42/EEC) or Active Implantable Medical Devices Directive (AIMDD), or already under the EU MDR (2017/745) or IVDR (2017/746). MDD/AIMDD products currently have a GB acceptance deadline of 30 June 2028, MDR/IVDR products 30 June 2030.

Northern Ireland shipments checked separately (Windsor Framework)Required

Shipments to Northern Ireland continue to require full EU MDR compliance with regular CE marking, independent of the GB transitional deadlines. Amazon does not automatically distinguish between GB and NI shipping on UK listings.

Continue conformity assessment or choose the UKCA route

While the transitional deadlines run, a valid EU CE mark is sufficient. For the long-term GB market, UKCA via a UK Approved Body may become necessary.

Estimated time: 4-26 weeks

Validity of EU Declaration of Conformity and Notified Body certificates checkedRequired

During the transitional period, a valid EU DoC with an active Notified Body certificate (for Class IIa+) is sufficient. The certificate must remain continuously valid – expiry without recertification leads to immediate loss of GB market authorisation.

If UKCA certification is planned: UK Approved Body contacted

UK Approved Bodies (e.g. BSI, SGS UK) are accredited separately from EU Notified Bodies. The number of UK Approved Bodies accredited for medical devices is limited, which can lead to long waiting times.

Appoint UK Responsible Person

Manufacturers not based in Great Britain must appoint a UK Responsible Person (UKRP) for every medical device – a precondition for MHRA registration.

Estimated time: 1-2 weeks

UK Responsible Person based in Great Britain appointedRequired

The UKRP registers the product with the MHRA, holds technical documentation and acts as the contact point for market surveillance. Unlike the EU Responsible Person under GPSR, the UKRP for medical devices is a specific role defined in the UK Medical Devices Regulations 2002.

UKRP appointment agreement

MHRA registration via DORS

Every medical device must be registered in the MHRA's Device Online Registration System (DORS) before being placed on the GB market, regardless of CE or UKCA status.

Estimated time: 2-4 weeks

Product registered in the DORS systemRequired

Registration is carried out by the UKRP (for non-UK manufacturers) or directly by the UK manufacturer. Required information: device class, GMDN code, CE certificate number or UKCA number, manufacturer details. Registration is subject to a fee and must be completed before selling in GB.

DORS registration confirmation

Adapt labeling and instructions for use to the UK

Labeling and documentation must reflect UK-specific information – UKRP address instead of or in addition to the EU Responsible Person, information in English.

Estimated time: 1-2 weeks

UKRP name and address stated on product or packagingRequired

While CE marking is used, the UKRP with a British address must be stated in addition to the EU-based responsible entity. With UKCA marking, the UKRP fully replaces the EU role.

Amazon.co.uk listing and vigilance

Amazon.co.uk requires proof of MHRA registration for medical device categories. Incidents must be reported to the MHRA instead of an EU authority.

Estimated time: 1-2 weeks

DORS registration number and UKRP details registered in Seller CentralRequired

Amazon UK can suspend medical device listings without proven MHRA registration. Keep the DORS number, CE/UKCA certificate and UKRP contact details ready for compliance requests.

Vigilance reporting route to the MHRA (not the EU national authority) set upRequired

Safety incidents involving GB customers are reported through the MHRA reporting system (Yellow Card / MORE), not through the EU vigilance system or Germany's BfArM. Reporting channels have been fully separate since Brexit.

Common Mistakes to Avoid

Equated EU MDR conformity with UK conformity

Consequence: A valid EU CE mark only permits GB sales within the transitional deadlines and only WITH additional MHRA registration and a UKRP. Without DORS registration, sales are not permitted even with a valid CE certificate.

Prevention: Complete MHRA registration via DORS and UKRP appointment in parallel with existing EU certification, not as an optional add-on step.

Treated the 2028/2030 transitional deadline as final

Consequence: The deadlines have already been postponed several times and are subject to an ongoing MHRA consultation (outcome still open as of early 2026). Relying blindly on a single deadline risks either premature UKCA investment or a late surprise if a deadline is not extended after all.

Prevention: Regularly check MHRA announcements and consultation outcomes before making certification or delisting decisions.

Northern Ireland shipping without separate EU MDR check

Consequence: Products prepared only for the GB transitional market (e.g. with an expired Notified Body certificate during a GB grace period) cannot lawfully be sold in Northern Ireland, where the EU MDR applies without restriction.

Prevention: Check Amazon shipping settings and compliance status for Northern Ireland separately from GB.

Confused UKRP with EU Responsible Person

Consequence: An EU authorized representative already appointed does not cover the UK requirement – these are two separate roles, defined differently in law, each with its own registration obligations.

Prevention: Appoint the UKRP as a distinct role and document it separately from the EU Responsible Person.

Vigilance incidents still reported only to the EU authority

Consequence: GB safety incidents not reported through the MHRA system violate the UK Medical Devices Regulations 2002 and can lead to withdrawal of MHRA registration.

Prevention: Set up separate reporting processes for GB and EU incidents and train vigilance staff accordingly.

Frequently Asked Questions

Q1Is my existing EU CE marking sufficient to sell on Amazon.co.uk?

Within the transitional deadlines, yes – MDD/AIMDD-certified products until 30 June 2028, MDR/IVDR-certified products until 30 June 2030 (as of the ongoing MHRA consultation Feb-10 Apr 2026 on possibly extending or removing these deadlines, outcome still open). However, MHRA registration via DORS and a UK Responsible Person are always additionally required – CE marking alone is not sufficient.

Q2What is the difference between the UK Responsible Person for medical devices and the EU Responsible Person under GPSR?

These are two separate roles, defined differently in law: the EU Responsible Person under GPSR (Art. 16) covers general product safety for the EU market, while the UK Responsible Person under the UK Medical Devices Regulations 2002 specifically covers MHRA registration and market surveillance for medical devices in Great Britain. Both must be appointed separately by the same manufacturer.

Q3Do I need separate approval for Northern Ireland?

Northern Ireland continues to follow the EU MDR fully with regular CE marking (Windsor Framework) – no UK transitional deadlines, no UKRP substitute for the EU role. If you also ship to Northern Ireland via Amazon.co.uk, the product must simultaneously meet the full EU MDR requirements.

Q4How long does MHRA registration via DORS take?

With complete documentation (valid CE certificate, GMDN code, UKRP agreement), expect 2-4 weeks. Missing or incorrect information significantly extends the process, as the MHRA raises queries.

Q5What happens if the MHRA consultation leads to stricter rather than looser rules?

The proposals consulted on in February/April 2026 aim at relief (extending the MDD/AIMDD deadline, removing the MDR/IVDR deadline) – a tightening is not envisaged based on the published consultation documents. Since the final outcome was not yet known at the time this checklist was written, check the current MHRA publication before major certification decisions.

CE MarkingHealth & MedicalUnited Kingdom 🇬🇧

Determine legal framework and transitional deadlines

Continue conformity assessment or choose the UKCA route

Appoint UK Responsible Person

MHRA registration via DORS

Adapt labeling and instructions for use to the UK

Amazon.co.uk listing and vigilance

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