MHRA Device Registration via DORS: Timing, Scope and Prohibited Claims

1. Key takeaways

All medical devices — including IVDs, custom-made devices, and systems and procedure packs — must be registered with MHRA before being placed on the market in Great Britain. The legal basis is reg 7A and reg 19 (general devices), reg 21A and reg 21B (active implantable medical devices), and reg 33A and reg 44 (IVDs). Registration is completed through the DORS (Device Online Registration System); overseas manufacturers register through their UKRP. Registration is not certification, approval or endorsement by MHRA, and it must not be presented as such, nor may the MHRA logo be used. Three points deserve emphasis for planning: the trigger for registration is the act of placing on the market, so it must be complete before the first supply; the scope is broader than most companies assume, covering refurbished and relabelled devices as well as packs and performance-evaluation IVDs; and the way registration is described publicly is itself regulated, since overclaiming the meaning of registration is one of the most common statements MHRA sees. This article sets out the registration duty, its timing, its scope and the rules on external claims.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 7A, reg 19 (registration of general devices and custom-made general devices); reg 21A, reg 21B (registration of active implantable medical devices and custom-made active implantable medical devices); reg 33A, reg 44 (registration of IVDs and IVDs undergoing performance evaluation); Part VI reg 53 (fees).
• SI 2026/197 (made 25 February 2026, in force 1 April 2026): reg 3 adds reg 53(2)–(7), including the rule in reg 53(5) that devices must not be placed on the market unless the fees due have been paid.
• Official guidance: GOV.UK, Register medical devices to place on the market.

The registration provisions are spread across the instrument because each device family has its own register and its own duty holder, but they share a common architecture: an information duty, a time point tied to placing on the market, and a fee consequence. Part VI reg 53 connects registration to payment, and the amendments made by SI 2026/197 sharpen that connection considerably: the new reg 53(2)–(7) introduced the annual fee structure and, critically, the rule that unpaid fees block placing on the market. The practical reading is that registration and fee status have become a single compliance question — a device that is registered but whose account fees are unpaid is still not lawfully placeable — and market-entry checklists should test both together rather than treating payment as a finance matter that compliance can assume away.

3. Expert insights

Insight 1: the registration time point is before placing on the market, not after sale. The official guidance is explicit: under the UK MDR 2002, MHRA must be notified before a device is placed on the market in Great Britain. Placing on the market and putting into service are two distinct legal definitions — for a device that is only put into service without being placed on the market, registration is encouraged but not mandatory; for a device that is both placed on the market and put into service, registration is mandatory. The distinction matters for equipment installed and used within a single organisation, for devices supplied to a single customer under manufacturing agreements, and for demonstration units. Each supply chain should map which legal definition its flows fall under before deciding whether registration applies.

Insight 2: the registration scope is wider than intuition suggests. Devices that must be registered include: Class I, IIa, IIb and III devices that you manufacture; Class I, IIa, IIb and III devices that you refurbish or relabel under your own name; any system or procedure pack containing at least one medical device; custom-made devices; IVDs that you manufacture; and IVDs undergoing performance evaluation. The refurbishment and relabelling item in particular is frequently overlooked, because companies think of it as a service rather than a placing of their own device on the market; under the registration rules, however, the entity that refurbishes or relabels under its own name takes on the registerable position. Assembling systems and packs is the second commonly missed trigger, since a pack containing even one medical device must itself be registered.

Insight 3: the nature of registration must be described accurately externally. The official guidance is explicit: registering with MHRA does not represent any form of endorsement, certification, approval or backing, so it is not permitted to claim that a device has been approved by MHRA, or to use the MHRA logo in marketing materials, on device packaging, in instructions for use, on laboratory documents or in any other document. This rule bites in exactly the places marketing teams like to quote: distributor decks, trade show stands, tender responses and website badges. A single approval-flavoured claim can mislead buyers and attract regulator attention, so every public statement about UK market access should describe registration as registration — nothing more.

4. Practical recommendations

GRZAN recommends building a registration-before-shipment control point: within the order and logistics process, make DORS registration confirmation a precondition for releasing any United Kingdom order. The control should sit with whoever releases goods physically, not only with the regulatory team, and it should verify both registration presence and fee status, since unpaid fees can block placing even where a registration exists. At the same time, review the website and market materials for phrases such as MHRA Approved or MHRA certified — this is one of the highest-frequency compliance wording errors in the United Kingdom market, and correcting it is cheap compared with the consequences of a misleading claim. Add registration wording to the standard marketing review checklist so that new campaigns, translations and distributor materials are checked before publication, and keep evidence of the corrections made.

5. Verification checklist

Before releasing the first United Kingdom order, confirm each of the following items.

• □ All registerable categories have been identified (including refurbished/relabelled devices, procedure packs, custom-made devices and performance-evaluation IVDs)
• □ Registration has been completed before placing on the market
• □ The overseas manufacturer has registered through the UKRP
• □ Placing on the market has been distinguished from putting into service only
• □ External materials contain no claims of MHRA approval and no use of the MHRA logo

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: end-to-end MHRA DORS registration through your UKRP, verification of registerable device categories, fee forecasting under the annual structure, and review of public claims so that registration is described accurately. For a consultation, contact us at info@grzanglobal.com.