Uk Mhra Medical Device Registration Service
MHRA medical device registration is a filing and record-maintenance process, not a product approval or conformity certificate. A registration service should identify the correct registrant, reconcile device data with conformity documents, submit through the right database, deal with MHRA queries and preserve a controlled record for later changes. This page concentrates on those execution tasks—not general UKCA strategy or the appointment terms of a UK Responsible Person.
Confirm the correct filing route before opening DORS
First distinguish Great Britain (England, Scotland, Wales) from Northern Ireland. Devices placed on the GB market generally need MHRA registration before first placing on that market; this includes IVDs, custom-made devices and systems/procedure packs. If a device is put into service only without being placed on the GB market, MHRA currently encourages but does not require registration: establish the facts before paying. All entries must reflect the actual applicable conformity route. MHRA registration is not certification, accreditation, endorsement or proof that an unsuitable product can be marketed.
Who files: the GB–Northern Ireland decision matrix
Use the destination and the manufacturer’s place of establishment to assign the filing owner. “Registration” below refers to the device filing, not appointment of an agent.
| Situation | Who acts and where | Filing decision |
|---|---|---|
| GB; UK-established manufacturer | Manufacturer maintains its DORS account. | Register relevant devices with MHRA before first GB placing; confirm classification and conformity evidence first. |
| GB; manufacturer established outside the UK | Appoint one UK Responsible Person (UKRP) for the manufacturer’s devices; UKRP registers with MHRA. | File in DORS with signed designation and accurate manufacturer data; GB importer details are supplied via manufacturer/UKRP. |
| Northern Ireland; non-custom-made device | For non-custom-made devices, the manufacturer registers the device in EUDAMED; the manufacturer and other applicable economic operators separately register their own actor roles. A GB manufacturer needs an EU/NI authorised representative. Actor registration alone does not register the device. | Since 28 May 2026, mandatory device registration for NI is in EUDAMED, not MHRA DORS. Any voluntary MHRA entry does not replace EUDAMED device registration. |
| Northern Ireland; custom-made device | Manufacturer, or NI-based authorised representative where appointed, follows MHRA custom-made procedure. | Register the custom-made device with MHRA within 28 days of making it available in NI; an EU-based authorised representative does not replace the manufacturer’s own filing. |
For an NI custom-made device, a manufacturer established outside the UK without an NI-based authorised representative must email Device.Registrations@mhra.gov.uk for MHRA filing instructions rather than assume the standard DORS account route applies. An EU-based representative does not submit that MHRA filing in the manufacturer’s place.
An importer is not automatically the MHRA registrant: for GB, the importer informs the manufacturer or UKRP, which submits the importer particulars. The NI branch uses separate EU economic-operator rules. A separate UK Responsible Person service deals with mandate and ongoing representation rather than this page’s submission work.
The registration dataset and evidence handover
Prepare a controlled source-of-truth file before entering DORS. The following is a filing-preparation checklist, not a claim that the MHRA requires every supporting technical-file page to be uploaded routinely; MHRA can request additional technical evidence during scrutiny.
| Workstream | Data / file to collect | Cross-check before filing |
|---|---|---|
| Legal manufacturer and authority | Exact legal name, address shown on labels, company type, administrative contacts; UKRP signed letter of designation if applicable. | Same entity appears across labels, declaration, certificates and DORS; designation names the correct manufacturer. |
| Device master data | Applicable legislation, device class, GMDN code and term, brand name, model/version, catalogue/reference, UDI-DI and Basic UDI-DI where applicable. | Trace each model to its GMDN/device record; confirm intended purpose and material attributes such as sterility, latex or MRI compatibility. |
| Conformity evidence | Applicable declaration of conformity or conformity-assessment certificate, approved/notified body particulars as relevant. | Check device scope, legislation, validity and any CE transitional evidence; keep full technical file ready for an MHRA follow-up request. |
| Economic operators | GB importer name and business address when relevant; UKRP manufacturer link; NI mandate for relevant custom-made filing. | No mismatch between importer, legal manufacturer and the party making the submission. |
| Special attachments | Component lists for systems/procedure packs; performance-evaluation declaration for study IVDs; other case-specific supporting evidence. | Do not apply an ordinary-device template to a special route. |
Submission workflow: seven checkpoints
The work is complete only after the device—not merely the user account—has confirmed registration:
These seven checkpoints apply to a required MHRA filing (normally a GB device registration, or the relevant NI custom-made route). They do not describe mandatory registration of non-custom-made NI devices in EUDAMED; first apply the destination matrix and obtain MHRA-specific instructions for the NI exceptions.
- Freeze the intended-use statement, market (GB or NI), risk class, conformity basis and responsible filing entity. Escalate unresolved classification questions before making an entry.
- Gather and reconcile the dataset and documents using the matrix above; verify GMDN categories against the current live DORS dataset.
- Create or access the appropriate Device Online Registration System (DORS) account. MHRA emails acceptance or rejection of a new account request; this is not device registration.
- For a UKRP, add the represented manufacturer and designation. Enter device records, linked products, importers and relevant supporting documents. DORS permits up to 100 GMDN devices and 20,000 products in one application.
- Obtain the manufacturer’s approval of the completed fields and follow the current DORS review, payment and submission screens. Pay any assessed statutory charge via DORS, not an external portal. If paying by BACS/CHAPS, use the unique DORS bank reference and upload proof of payment before the application is submitted. Record final submission and payment status; do not confuse either with MHRA device-registration confirmation.
- Monitor MHRA messages; respond to requests for corrected attributes or technical documents with version-controlled evidence. No fixed acceptance period or guaranteed outcome should be promised.
- Receive confirmation that the device registration is complete, retain the DORS reference and submitted data, and cross-check any public listing (PARD) without treating it as an approval.
Service deliverables should include a filing register showing owner, market, GMDN, models, document revisions, submission date, fee reference, regulator correspondence and confirmation status.
2026 fees and payment control
Since 1 April 2026, MHRA fees are annual and linked to chargeable GMDN Level 2 categories (or Level 1 where no Level 2 exists), rather than a flat fee for each product or each application. For the 1 April 2026–31 March 2027 period, the published rate is £300 per chargeable category per year. Additional categories entered during the fee year are charged pro rata through DORS; several products in an already-paid category do not automatically trigger another category fee. The final category allocation and payable amount must be checked in DORS.
The published standard annual-fee rule requires payment in full within 90 days of 1 April; the exceptional extension to 31 July applied to 2026 only. The MHRA accepts DORS payment from UK-based manufacturers, UK Responsible Persons and Northern Ireland authorised representatives, not an unrelated filing consultant acting as an independent payer.
The former annual Renew Registration function was removed on 1 April 2026; routine record review and annual payment remain necessary. MHRA’s exceptional 2026 annual-fee deadline extension to 31 July 2026 has already passed and is not a permanent annual deadline. From April 2026, updating a company name/address or uploading a replacement letter of designation carries no separate charge. Keep professional service fees separate from statutory MHRA charges. Fees for optional NI DORS registrations require their own check.
Special filings that must not be treated as ordinary devices
- Systems/procedure packs: include the relevant GMDN device, at least one underlying product and a list of all possible components as required by MHRA.
- IVDs undergoing performance evaluation: for a GB study, verify the MHRA registration requirement by study commencement and prepare the required performance-evaluation declaration. For NI, check the distinct EU IVDR study and EUDAMED requirements before choosing any MHRA route. This is not an ordinary marketed-device filing.
- Coronavirus antigen/molecular tests: MHRA says registration applications are not accepted before CTDA unless the applicable exemption is established. Check this upstream.
- CE transitional cases: an expired-looking certificate or an EU MDR/IVDR legacy route may require specific extension evidence and a different record basis; never upload a certificate without verifying the applicable transitional conditions.
Delay and rework triggers: an operational fault table
| Trigger | Practical consequence | Control / corrective action |
|---|---|---|
| Account created but no device confirmation | The applicant incorrectly believes market filing is complete. | Keep the product on hold for GB supply until MHRA confirms its registration. |
| Wrong GMDN, class, legislation or mismatched brand/model | Data scrutiny, resubmission or later re-registration may be needed. | Reconcile DORS against labels, declaration, certificates and the model matrix before payment. |
| UKRP designation missing / wrong legal manufacturer | Represented-manufacturer entry may be blocked or challenged. | Verify the single UKRP mandate and identity chain before account submission. |
| Payment lacks DORS bank reference | Payment matching and processing may be delayed or account affected. | Use the exact unique BACS/CHAPS reference and retain the remittance evidence. |
| NI non-custom device incorrectly treated as mandatory DORS / discontinued devices retained | Wrong database, duplicated work or unnecessary future charges. | Route NI non-custom devices to EUDAMED; promptly remove devices no longer placed on the market after checking residual vigilance duties. |
After confirmation: updates, fees and vigilance
Registration maintenance is a separate controlled workstream; it cannot be replaced by an old-style periodic “renewal” button.
- Review DORS records and chargeable GMDN categories regularly and before the 31 March fee snapshot. Confirm names, contacts, manufacturer relationships, marketed devices and importers.
- Record changes to a device’s class, GMDN, legislation, sterility, certain identifiers or UKRP. MHRA may require a new registration; fees depend on whether a new chargeable category is added. Simple contact/product additions and permitted conformity-document updates can be free.
- When products stop being placed on the GB market, assess de-registration. Removal does not erase post-market surveillance or vigilance obligations for units already supplied; the GB PMS rules revised in 2025 still matter.
- Maintain copies of submissions, payment receipts, designation, conformity basis, regulator correspondence and a change log. Investigate suspended accounts and missing PARD visibility before further GB supply.
- When replacing the only registered device in a paid GMDN category, register the replacement first and unregister the old device afterwards where appropriate; MHRA warns that the reverse order may cause another pro-rata category fee. Confirm the correct clinical and conformity record before doing so.
What a filing-execution service should hand over
A properly scoped filing service should provide: (1) jurisdiction/registrant decision; (2) a verified DORS input workbook and evidence index; (3) a submitted application and exact payment reference; (4) an MHRA query-and-response trail; (5) confirmation and a change-control handover. Neither the consultant nor MHRA registration replaces conformity assessment or the manufacturer’s legal duties.
For unresolved classification or CE/UKCA pathway questions use the MHRA registration consultant analysis; for contractual UKRP tasks use the UKRP representation page. Registration execution begins only when those upstream assumptions can be documented.
Questions about actual MHRA filing
Does an approved DORS account mean we can place our Class IIa device on the GB market?
No. MHRA expressly requires device details and confirmation of device registration. The separate conformity-assessment basis must also be valid; an account email is not device registration.
We manufacture in Germany and have a UK importer. Can that importer file instead of a UKRP?
A GB importer must notify the manufacturer or UKRP of its intention to import. A non-UK manufacturer must appoint a single UKRP, which submits the device registration and importer particulars; importer status alone is not a substitute.
Is MHRA DORS still compulsory for a standard device shipped only to Belfast in October 2026?
Generally no for a non-custom-made device: from 28 May 2026 mandatory device registration for the NI market is in EUDAMED. Confirm MDR/IVDR, the relevant economic operator and NI conformity obligations. Custom-made devices remain a separate MHRA route.
Will adding three more models in an existing GMDN category mean three more £300 fees?
Not merely because they are models. Under the 2026 category-based system, adding products to an already-paid category generally creates no further category charge; check whether the new devices actually occupy another chargeable category.
Can we fix a wrong class or replace our UKRP by editing one DORS field?
Do not assume so. MHRA lists device-characteristic and UKRP changes among cases requiring a new device registration. Check the new category fee implication and coordinate the change before further supply.
Must a hospital register a device made solely for its own use?
First distinguish putting into service only from placing on the GB market. MHRA states registration is encouraged but not required for devices only put into service. Other product safety and health-institution rules still need independent analysis.
Official regulatory references
Primary sources: MHRA registration guidance; MHRA Northern Ireland and UK regulatory guidance; MHRA April 2026 fees guide; MHRA post-market surveillance guidance.