IVD Performance Evaluation Registration in the UK

1. Key takeaways

The UK operates a dedicated pathway for IVDs in the performance evaluation stage: reg 43 (devices for performance evaluation) governs the procedure, and reg 44 requires IVDs that are to be subject to performance evaluation to be registered with the MHRA. In DORS, such devices must carry the status of performance evaluation, and the subsequent move to formal placing on the market requires re-registration. Under the fee rules, where the new registration falls within the same GMDN category as the original performance evaluation registration, no additional fee is charged. The headline point is easily missed: registration is required before the evaluation stage, not only at commercialisation. Many manufacturers, especially those arriving from markets where only marketed products are registered, assume that an unmarked, unreleased evaluation device sits outside the regulatory perimeter. In the UK it does not. The device, its DORS status, its GMDN classification and the eventual transition to market status all need active management from day one, and the sections below set out the provisions, the fee logic and the tracking practices that keep that management visible. GRZAN recommends reading the registration obligation as a launch-critical item: it belongs on the same checklist as ethics review and study logistics, not on an administrative afterthought list. Manufacturers should also note that the registration applies to devices made subject to performance evaluation, which reaches products used internally as well as those evaluated for third parties.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 43 (devices for performance evaluation), reg 44 (registration of IVDs placed on the market or made subject to performance evaluation) and reg 33A (registration of IVDs).
• SI 2026/197 (made 25 February 2026, in force 1 April 2026): reg 3 adds regs 53(2) to (7), covering the annual maintenance fee and the GMDN category rules.
• Official guidance: GOV.UK, Register medical devices to place on the market, including the section on the fee rules for changing a registration.

3. Expert insights

Insight one: performance evaluation devices must also be registered, which differs from some markets. The official guidance lists the mandatory registration scope explicitly, and it includes IVDs undergoing performance evaluation. This runs counter to the intuition that registration belongs only at the point of sale, and it is one of the most commonly missed obligations. A performance evaluation that proceeds without DORS registration is not a minor formality gap; it is an unregistered device in the regulator’s terms, discoverable whenever the MHRA examines the company’s registration data or the device itself surfaces in the market. Because the obligation is easy to overlook, GRZAN suggests assigning it an owner within the study team and confirming it in writing at project kickoff.

Insight two: a status change triggers re-registration, and the fee depends on the GMDN category. The official guidance states that changing the status of an IVD, for example from performance evaluation to new, requires the device to be re-registered. Critically, where the GMDN category of the new registration is the same as that of the original performance evaluation registration, no fee is charged. The financial consequence therefore hinges on classification discipline. If the GMDN code and category selected at the evaluation stage accurately reflect the device as it will be marketed, the transition to market status carries no new fee burden; if the classification changes, a new fee category may arise. The classification chosen at evaluation stage should therefore be reviewed by whoever owns annual fee planning, not only by the study team.

Insight three: performance studies in Northern Ireland follow the EU IVDR procedure. Part 3A of SI 2021/905 (regs 17B to 17F) governs performance studies under the EU IVDR, including the legal representative and contact person, ethics review, arbitration following a refusal, compensation for damage and record retention. This is a separate procedure from GB’s reg 43. A sponsor running studies in both territories must map each study to its own regime, its own ethics channel and its own documentation set, exactly as with clinical investigations of devices. Sponsors running studies in both territories should keep the two procedures in separate workstreams, since mixing their terminologies creates precisely the form-matching problems described above.

4. Practical recommendations

GRZAN recommends maintaining a dedicated status tracking table for every performance evaluation project. Its fields should include: the list of devices under evaluation; the DORS registration number for each; the GMDN code and category; the current status (performance evaluation or new); and the expected date of transition to market status. Before the transition, the table should be reviewed to confirm whether the GMDN category will change, because that single determination decides whether a new annual fee category arises and how the following year’s fee calculations should be budgeted. GRZAN suggests assigning ownership of the table to a named person and reviewing it at fixed intervals, so that status changes, re-registrations and fee consequences are handled as planned events rather than as discoveries made during registration housekeeping. For projects with uncertain transition dates, GRZAN suggests recording the decision criteria that will trigger the re-registration, so the move to market status happens on evidence rather than on memory.

5. Verification checklist

• □ IVDs undergoing performance evaluation are registered in DORS with the correct status
• □ The GMDN code and category are recorded
• □ A transition-to-market plan exists and its fee impact has been calculated
• □ Performance studies in Northern Ireland comply with SI 2021/905 Part 3A
• □ Ethics review and the related procedures have been completed

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the UK market with the preparation and maintenance of registration documentation and conformity documentation. Our services for the UK market include:

• UK Responsible Person (UKRP) appointment and authorisation letter support
• Full MHRA registration (DORS) filing and account lifecycle management
• Device classification, GMDN code selection and annual registration fee calculation
• Great Britain and Northern Ireland dual-pathway design and UK(NI) solutions
• Post-market surveillance (PMS) system setup, PMSR/PSUR preparation and vigilance reporting
• Serious incident and field safety corrective action (FSCA) emergency response
• UK regulatory change monitoring and compliance gap assessment

For tailored support with IVD performance evaluation registration and related documentation, contact GRZAN at info@grzanglobal.com.