Clinical Investigation Procedures and Notification in the UK

1. Key takeaways

Running a clinical investigation of a medical device in Great Britain requires following the procedures in reg 16 (general devices) and reg 29 (active implantable devices) of UK MDR 2002, together with ethics committee review; the associated fees are set out in reg 56 of Part VI. Northern Ireland follows a different procedure altogether: clinical investigations there are governed by Part 3 of SI 2021/905 (regs 11 to 17A), with applications submitted under EU MDR Article 70(1) and a consultation meeting available on request under reg 17A. The split is not a technicality. It determines which authority is contacted, which forms are used, which ethics route applies and which fee provisions are cited in the study budget. Sponsors planning multi-site trials should therefore treat territory and legal pathway as the first two planning decisions, made before protocol finalisation, because discovering late that a site sits under a different legal regime forces procedural rework precisely when timelines are least able to absorb it. The sections below map the two regimes, their fee provisions and the practical controls that keep a cross-territory programme compliant. GRZAN recommends reading them with a live trial plan open beside them, so that each procedural element found here can be cited in the plan from the start rather than patched in later.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 16 (the procedure for clinical investigations of general devices), reg 29 (the procedure for clinical investigations of active implantable devices), reg 43 (devices for performance evaluation of IVDs), Part VI reg 52 and reg 56 (fees for clinical investigation notifications), reg 56D (fees for pre-consultation meetings) and reg 56E (fees for regulatory consultation meetings).
• The Medical Devices (Northern Ireland Protocol) Regulations 2021 (SI 2021/905): reg 11 (ethics review), reg 12 (prior authorisation by the competent authority), reg 13 (arbitration following refusal), reg 14 (compensation for damage), reg 16 (fees for clinical investigations) and reg 17A (consultation meetings, with fees adjusted by SI 2025/749 with effect from 16 July 2025).

3. Expert insights

Insight one: clinical investigations in GB and NI sit under two separate legal regimes. Regs 16 and 29 belong to UK MDR 2002 and apply in Great Britain; Part 3 of SI 2021/905 governs Northern Ireland under EU MDR. In a multi-centre trial where sites span both territories, both sets of procedures must be followed. This is a genuinely dual-track situation, not a matter of choosing one route and applying it everywhere. The application documents, the authorisation pathway and the ethics arrangements differ between the two regimes, and a sponsor who assumes a single UK-wide process will discover the divergence at the worst possible time, when sites and budgets are already committed. GRZAN recommends documenting the regime determination for each site in the trial master file, so that the basis for every procedural choice remains auditable long after the planning team has moved on.

Insight two: the fee provisions are scattered. On the Great Britain side, the relevant provisions are reg 56 (clinical investigation notification fees), reg 56D (pre-consultation meetings) and reg 56E (regulatory consultation meetings). On the Northern Ireland side, they are reg 16 (clinical investigation fees) and reg 17A (consultation meeting fees, adjusted by SI 2025/749 with effect from 16 July 2025). A trial budget must cite each provision separately according to where each activity takes place. GRZAN recommends building the budget from a fee map rather than from a single rate card, so that every chargeable step, notifications, meetings and any arbitration following a refusal, is traceable to its own legal basis. Fee provisions should also be revisited whenever the underlying instruments are amended, as the NI consultation fee adjustment of July 2025 illustrates.

Insight three: IVDs run performance evaluation, not clinical investigations. The corresponding procedure for IVDs is reg 43 (devices for performance evaluation), and both the terminology and the process differ from clinical investigations of general devices. This vocabulary gap is more than cosmetic: IVD companies that map their performance studies onto clinical investigation forms and timelines routinely generate paperwork the regulator does not recognise, and miss requirements specific to the performance evaluation route. Correct terminology at the planning stage is the cheapest possible compliance control, and using the correct term from the first planning document onward keeps downstream registrations, ethics submissions and budget lines consistent with one another.

4. Practical recommendations

GRZAN recommends completing a territory and pathway confirmation table before the study protocol is finalised. Its fields should cover, for each site: the site’s location (GB or NI); the device family (general, active implantable or IVD); the applicable procedural provisions (reg 16, reg 29 or reg 43 on the GB side, or SI 2021/905 regs 11 to 17A on the NI side); the ethics review channel; and the fee provisions and amounts that apply. GRZAN suggests requiring this table to be signed off before the study budget is approved. The purpose is simple: no procedural step should be discovered after the budget is locked, because fee provisions and authorisation routes are far easier to plan around in advance than to retrofit once contracts, insurance and site agreements are already in place and any change ripples through the whole programme. GRZAN also suggests attaching the completed table to the budget approval record, so the pathway decisions carry the same documentary weight as the financial ones.

5. Verification checklist

• □ The location of each investigation site, GB, NI or both, has been confirmed
• □ The applicable procedural provisions have been determined (reg 16 / 29 / 43 / SI 2021/905)
• □ Ethics review has been initiated or completed
• □ The fee provisions have been cited and included in the budget
• □ Where consultation meetings are needed, they are arranged under reg 56D / 56E / SI 2021/905 reg 17A

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 UK clinical investigation planning and regulatory documentation, contact GRZAN at info@grzanglobal.com.