DORS Registration in Practice: Data Fields, Consistency Checks and Legacy Records

1. Key takeaways

DORS collects information at two tiers. At the organisation level: the legal entity name and address — which must match exactly what appears on the label and packaging — the organisation type, up to 15 named administrative contacts, and the UKRP’s letter of designation. At the device level: the regulation and classification relied on, the GMDN code and term, the Basic UDI-DI (where applicable), the brand name, model and catalogue numbers, the UK approved body or EU notified body, and the certificates or declaration of conformity. An organisation address that does not match the label, and GMDN code mismatches, are the two most frequent reasons for registrations being sent back. The pattern behind both is the same: DORS data is compared against documents that already exist — the label artwork, the declaration of conformity, the certificate — so every field entered into the system should be copied from a source document rather than typed from memory. This article walks through the two data tiers, the pre-registration checks, MHRA’s verification activity, and the special path for legacy registrations.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 7A, reg 19, reg 21A, reg 21B, reg 33A, reg 44 (registration obligations and information requirements); reg 2 (definitions).
• Official guidance: GOV.UK, Register medical devices to place on the market (the Information required when registering your devices with the MHRA section); MHRA, Device Registration Reference Guide.
• SI 2026/197 (in force 1 April 2026): reg 3(7) defines GMDN and registration category.

The information requirements trace directly back to the registration provisions: each of reg 7A, reg 19, reg 21A, reg 21B, reg 33A and reg 44 prescribes the information that must be notified, and the guidance operationalises those lists into the DORS data fields. Reg 2 matters more than its position at the front of the instrument suggests, because the definitions decide whether a product is a device at all, and several of the data fields — classification, the applicable regulation — flow from definitional conclusions. SI 2026/197 adds a fee dimension to the same fields: reg 3(7) defines GMDN and registration category, which means the GMDN code chosen during registration now also determines the annual fee calculation. Registration data quality is therefore both a compliance question and a cost question at the same time.

3. Expert insights

Insight 1: the organisation address must match the label exactly. The official guidance requires the manufacturer details provided to be the legal entity name and address shown on the device label and packaging. This is a field that can be compared mechanically — an inconsistency between the DORS data and the public PARD (Public Access Registration Database) will directly expose a compliance problem, because anyone, including distributors, buyers and competitors, can see the mismatch. The practical discipline is to treat the label artwork as the master source: copy the entity name and address from it character by character, including legal suffixes and punctuation, and re-verify whenever the label is revised. Where an entity has moved premises but the label still shows the old address, the address entered in DORS should follow the label until the artwork itself is updated.

Insight 2: before registering, confirm whether the product is a device at all. The official guidance advises that, before attempting registration, you should confirm that the product meets the definition of a medical device or IVD as explained in reg 2 (as amended); where there is doubt — in particular when registering on the basis of self-declared conformity — the MHRA guidance on Borderline products should be consulted. This step prevents two opposite errors: registering a product that is not a device, which pollutes the fee calculation under the 2026 structure, and failing to register a genuine device, which is a direct breach. Borderline calls should be documented with reasons, because the analysis may be revisited years later.

Insight 3: MHRA carries out active data verification. The official guidance states that, as part of the data validation and review of registration submissions, MHRA may request further technical documentation to demonstrate that the product meets the requirements of the medical devices regulations. A registration submission is not the finish line. Registrations should therefore be prepared on the assumption that the underlying evidence will be inspected: certificates, declarations of conformity and technical documentation must be retrievable quickly, and the person named as the administrative contact must actually be able to respond. Treating the submission as a self-contained data-entry exercise leaves the organisation exposed when the follow-up request arrives.

Insight 4: legacy registrations need to be reviewed. Organisations that registered before 1 July 2018, whose registration number begins with CA or IVD, or whose registration does not appear on PARD, must re-register the organisation details and devices in DORS and provide more detailed information and upload conformity assessment documentation. These legacy records predate the richer data set now expected, so re-registration is effectively a first registration in disguise: the same consistency checks, the same evidence uploads and the same GMDN care apply. Companies that have inherited a portfolio through acquisition should specifically check for CA or IVD prefixed numbers among the inherited registrations.

4. Practical recommendations

GRZAN recommends running a three-way consistency check before every submission: the entity name, address, device name, model and GMDN code across the label specimen, the declaration of conformity and the DORS entry must agree field by field. Prepare the PDFs of the conformity documents (certificates, the declaration of conformity) in advance so the upload step does not stall the submission, and name administrative contacts who are reachable and staffed for queries rather than generic inboxes. For accounts that are already registered, establish a quarterly review mechanism instead of waiting for a reminder email from MHRA: verify that new models and catalogue numbers have been added, that discontinued items have been removed, and that organisation details still match the current label. Log each review with a date and a reviewer, so the organisation can demonstrate a living data-quality process.

5. Verification checklist

Before submitting or re-verifying a registration, confirm each of the following items.

• □ The organisation name and address match the label specimen
• □ The GMDN code and term have been checked
• □ The Basic UDI-DI has been entered (where applicable)
• □ The conformity documents (certificate/declaration of conformity) are ready for upload
• □ Legacy registrations (before 1 July 2018) have been re-registered

Regulatory information verified as of 29 October 2026.

• Appointment of the UK responsible person (UKRP) and support for signing the letter of designation
• End-to-end MHRA registration (DORS) filing and account lifecycle management
• Device classification assessment, GMDN code selection and annual registration fee calculation
• Dual-pathway design for Great Britain and Northern Ireland, including the UK(NI) option
• Post-market surveillance (PMS) system setup, PMSR/PSUR preparation and vigilance report submission
• Emergency handling of serious adverse events and field safety corrective actions (FSCA)
• Monitoring of UK regulatory changes and compliance gap assessment

Working with GRZAN. GRZAN Global supports manufacturers entering the United Kingdom market with the full scope of UKRP and fee-budgeting services described above: preparing and validating DORS organisation and device data, resolving GMDN and label consistency issues, re-registering legacy records, and forecasting annual registration fees by GMDN category. For a consultation, contact us at info@grzanglobal.com.