A surgical instrument, a blood-glucose meter and a wheelchair cushion can all sit in the same shipment, yet each one has to clear the same gate before it can be sold: is it correctly marked, and is it registered? If you plan to import medical devices UK-side and place them on the Great Britain market, customs duty is the easy part — the harder questions are conformity marking and registration with the MHRA. Get either wrong and the goods cannot lawfully be sold, however cleanly they cleared the border. This guide walks through what the gov.uk rules actually require.
UKCA, CE or both: which marking applies
Great Britain currently recognises two conformity routes for medical devices. The UKCA marking is the UK’s own route to market, but CE-marked devices are still accepted during transitional periods, and gov.uk confirms that a device can carry both the CE and UKCA markings on its labelling at the same time. That flexibility matters: it means you usually do not have to re-certify an existing CE-marked device immediately to keep selling it in GB.
Devices are grouped by risk class — Class I, IIa, IIb and III, plus in vitro diagnostic devices (IVDs), systems, procedure packs and custom-made devices. Higher-risk classes need an approved body to assess conformity, while some Class I devices can self-declare under the Medical Devices Regulations 2002. Whichever route you use, the conformity assessment has to be in place before the device reaches the market.
The CE acceptance timeline you must track
The single most important thing to diary is when CE acceptance ends for your device type, because it depends on which EU legislation the device was certified under. According to gov.uk, CE-marked devices are accepted in Great Britain as follows:
- General medical devices certified under the EU MDD or AIMDD: until the sooner of certificate expiry or 30 June 2028.
- In vitro diagnostic devices certified under the EU IVDD: until the sooner of certificate expiry or 30 June 2030.
- Devices certified under the EU MDR or IVDR: until 30 June 2030.
Separately, the general UKCA labelling easement — which lets the UKCA marking sit on a label or accompanying document rather than the product itself — runs until 11pm on 31 December 2027 for the product types it covers. These dates move with policy, so always confirm the live position on gov.uk before you plan a product launch around them.
Registering with the MHRA before you sell
Marking alone is not enough. The Medicines and Healthcare products Regulatory Agency (MHRA) requires that all medical devices — including IVDs, custom-made devices and systems or procedure packs — are registered with it before being placed on the Great Britain market. Registration applies across Class I, IIa, IIb and III, and to anyone who sells, leases, lends or gifts a device they have manufactured, refurbished or re-labelled under their own name.
One point that trips up newcomers: registration is an administrative gate, not a quality stamp. gov.uk is explicit that registering with the MHRA “does not represent any form of accreditation, certification, approval or endorsement”. You therefore cannot use the MHRA name or logo in your marketing, packaging or instructions for use to imply approval.
The UK Responsible Person: a must for overseas makers
If the manufacturer is based outside the UK — which covers most EU and global brands shipping into GB — they must appoint a single UK Responsible Person to take responsibility for all of their medical devices. The UK Responsible Person handles MHRA registration and assumes defined duties under a legal contract with the manufacturer.
This role also has a labelling consequence. Where the UKCA marking has been affixed, the name and address of the UK Responsible Person must appear on the product labelling, the outer packaging, or the instructions for use. So the decision about who acts as your UK Responsible Person feeds directly into your artwork and packaging, not just your paperwork.
Because the conformity and registration steps sit on top of normal import formalities, it pays to model the full cost early. You can estimate duty, VAT and the wider landed cost with Easy Clearance’s UK import cost calculator before you commit to a shipment.
Import medical devices UK: a practical checklist
- Classify the device (Class I, IIa, IIb, III, IVD, custom-made or procedure pack).
- Confirm the conformity route — UKCA, or CE under a transitional deadline — and whether an approved body is needed.
- Diary the relevant CE acceptance end date for your device’s certification (MDD/AIMDD, IVDD, MDR or IVDR).
- Register every device with the MHRA before it is placed on the GB market.
- If the manufacturer is outside the UK, appoint a single UK Responsible Person.
- Add the UK Responsible Person’s name and address to labelling, packaging or the instructions for use where UKCA is affixed.
- Prepare the standard import paperwork: EORI, commercial invoice, accurate value and the correct commodity code.
Compliance-led import categories share a similar rhythm — see how it plays out for another regulated product in our guide on importing cosmetics to the UK.
Mini-FAQ
Can I still sell CE-marked medical devices in Great Britain? Yes, during transitional periods. General devices under the MDD/AIMDD are accepted until the sooner of certificate expiry or 30 June 2028; IVDD devices until 30 June 2030; and MDR/IVDR devices until 30 June 2030. Confirm the current dates on gov.uk.
Do I have to register a device with the MHRA? Yes. All medical devices, including IVDs, custom-made devices and procedure packs, must be registered with the MHRA before they are placed on the Great Britain market.
What is a UK Responsible Person? If the manufacturer is based outside the UK, they must appoint a single UK Responsible Person to register the devices and take on defined responsibilities, with their name and address shown on labelling where UKCA is affixed.
Sources (gov.uk): Regulating medical devices in the UK; Using the UKCA marking.
