Medical Device Registration Services In The Uk
MHRA medical device registration is a filing step, not a product approval. For Great Britain, identify the responsible applicant, verify the conformity route and prepare product-level identifiers before submitting via the Device Online Registration System (DORS). The Northern Ireland route is different.
Choose the filing route before creating the application
The decisive first question is whether the device is first placed on the Great Britain market, placed on the Northern Ireland market, or only put into service without market placement. Do not treat these as one UK filing.
| Destination or situation | Registration action |
|---|---|
| Great Britain (England, Scotland, Wales) | Register medical devices, IVDs, custom-made devices and systems/procedure packs with MHRA before placing them on the market. A valid applicable conformity route is required separately. |
| Northern Ireland — devices other than custom-made | Since 28 May 2026, register applicable devices in EUDAMED before EU/Northern Ireland market placement; MHRA device registration is no longer required for these devices. EU MDR/IVDR obligations and representation must be checked. |
| Northern Ireland — custom-made devices | The MHRA custom-made registration route continues. The MHRA specifies registration within 28 days of first making available; an EU/Northern Ireland authorised representative may be needed depending on manufacturer location. |
| Device only put into service in Great Britain | Where genuinely put into service without being placed on the market, MHRA says registration is encouraged but not required. Analyse the factual supply chain first; ordinary supply normally entails market placement. |
Assign the applicant and evidence owner
The applicant in DORS must match the legal role. An importer is not automatically the manufacturer or the UK Responsible Person (UKRP).
| Party | Filing responsibility |
|---|---|
| Manufacturer established in the UK | Controls intended purpose, classification, conformity evidence, accurate manufacturer identifiers and registration of its relevant devices. |
| Manufacturer outside the UK / designated UKRP | The non-UK manufacturer appoints a single UKRP for its devices on the GB market by a written letter of designation; the UKRP registers the devices and communicates with MHRA. Manufacturer retains product compliance responsibilities. |
| Great Britain importer | Notifies the manufacturer or UKRP of its intention to import; that manufacturer/UKRP submits the GB importer details, including place of business, to MHRA. A distributor that does not import is not registered solely for distribution. |
Build a DORS-ready data and evidence pack
Separate mandatory registration fields and uploads from the wider technical file that MHRA may request for scrutiny. The following is an execution checklist, not a substitute for conformity assessment.
- Legal identity: manufacturer legal name/address as shown on labelling, company type, administrative contact, UKRP designation contract where applicable, and importers to be linked.
- Device identity: applicable legislation and class, accurate GMDN term/code, brand/trade name, model/version, catalogue/reference number, basic UDI-DI and UDI-DI where applicable, and attributes such as sterility, latex and MRI compatibility.
- Conformity documents: applicable declaration of conformity or certificate, correct issuing body and certificate scope/validity; have technical documentation ready if MHRA requests it. Registration is not MHRA certification.
- Special routes: custom-made statements and system/pack component lists where relevant; performance-evaluation IVD declaration, and CTDA status where coronavirus tests are in scope. Do not assume standard-device uploads cover these cases.
Execute and close the DORS application
- Confirm intended purpose, risk class and GB/NI destination; resolve uncertainty before using a self-declaration route.
- Confirm conformity evidence and whether existing CE marking is acceptable for the specific device and date; a CE mark alone does not replace MHRA registration in Great Britain.
- Establish the DORS organisation account; for a foreign manufacturer, ensure the UKRP designation and represented-manufacturer record are in place.
- Create device/GMDN entries and product variants, attach the relevant conformity documents, verify importer and identification data, and review the complete application.
- Submit, pay the applicable fee through DORS, retain the reference, answer MHRA data/technical-document requests, and verify that actual device registration has been confirmed before GB market placement. An account or draft is not a registered device.
Budget the current registration fee rather than an obsolete application charge
From 1 April 2026, the MHRA annual charge replaced the previous one-off device application fee. For 1 April 2026–31 March 2027, the stated rate is £300 per GMDN Level 2 category (or Level 1 if there is no Level 2), not £300 per product. A category appearing across multiple products is counted once for the manufacturer; a new registration during the fee year is pro-rated.
Confirm actual GMDN category coverage and the current MHRA fee schedule before filing. Fees must be settled as required for lawful placement; payment occurs through DORS. UKRP designation-letter uploads and organisation name/address updates no longer attract separate charges from 1 April 2026.
Reject, delay or misroute triggers to check before submission
- A declaration cites the wrong legal route, the certificate is expired without an evidenced lawful extension, or product scope falls outside its certificate: stop and resolve conformity status.
- The GMDN term, class, trade name, model or UDI differs across labels, certificate and DORS: reconcile the device/product inventory before upload.
- A foreign manufacturer has no valid exclusive UKRP appointment, or the represented manufacturer and importer links are missing: correct the actor records first.
- The file lacks conformity evidence, a special IVD/custom-made/pack attachment, or a response to MHRA scrutiny: prepare the missing documents before claiming completion.
- The application is saved or paid but MHRA has not confirmed device registration: do not present it as an approval or start GB market placement.
Maintain the registration after the first successful filing
Keep registered devices and importer records accurate; report relevant changes. A change of UKRP requires new registration, while some legislation, class, device-attribute or identifier changes may also require re-registration. The DORS “Renew registration” function was removed in April 2026, but regular review remains necessary.
Track category-based annual fees, certificate validity, device discontinuation and the end of market placement. GB post-market surveillance and vigilance rules strengthened from 16 June 2025 and may continue to apply to devices already supplied even after registrations are withdrawn.
What this registration service does — and does not do
The service deliverable is an applicant-and-device register, consistency-reviewed dossier, completed submission, regulator-query log and ongoing change register. For broad classification strategy and regulatory gap analysis rather than filing execution, see UK MHRA medical device registration consultancy. Neither filing nor use of DORS substitutes for conformity assessment.
Official regulatory sources
Frequently asked filing questions
Is CE marking enough for Great Britain?
No. Where a CE route remains accepted for the specific device, its conformity evidence can support GB market access, but MHRA registration must still be completed before placing the device on the GB market. Check the applicable transition period and validity.
Can an overseas manufacturer submit without a UKRP?
Not for ordinary GB market placement: the non-UK manufacturer must appoint a single UK Responsible Person, who handles the MHRA registration on the manufacturer’s behalf.
Do I use DORS for every Northern Ireland device?
No. Since 28 May 2026, non-custom-made devices generally require EUDAMED registration for Northern Ireland rather than MHRA DORS registration. Custom-made devices retain a separate MHRA registration path.
Does a model or GMDN change require a new registration?
It depends on which field changes and whether DORS permits an amendment. Certain changes, including a changed legal regime or UKRP, require new registration; check the MHRA change list and fee category before editing.
Does a DORS account or receipt prove MHRA approval?
No. Wait for confirmation of the specific registered devices. MHRA registration is not product certification, approval, accreditation or an MHRA endorsement.