Reporting Through the MHRA MORE Portal: Requirements and Preparation

1. Key takeaways

The Manufacturer Online Reporting Environment (MORE) is the portal designated by MHRA for the submission of vigilance reports. Serious adverse incident reports, trend reports and FSCA reports for both Great Britain and Northern Ireland must all be submitted through MORE. Combined with the deadline rules of Part 4A, this means that portal readiness is a precondition for meeting the 2-, 10- and 15-day deadlines.

The point deserves emphasis because portal readiness is routinely treated as administrative housekeeping rather than as a compliance-critical control. Under Part 4A the deadlines start on awareness of an incident, and awareness can arrive on any working day at any hour. If the account has not been opened, if user permissions are not configured, or if report templates have never been test-filled, the time available for the actual submission shrinks to whatever can be improvised after the clock has already started. For manufacturers entering the market for the first time, and for distributors becoming manufacturers through own-brand labelling, the account setup and validation exercise belongs on the pre-launch checklist next to registration and classification, not on a post-launch to-do list that competes with daily operations. The same logic applies to changes of personnel: when the operator who holds the account credentials leaves the company, the replacement must be onboarded before the next incident, not after.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): Part 4A reg 44ZH (initial reports), reg 44ZI (final reports), reg 44ZJ (FSCA), reg 44ZN (trend reporting) and reg 44ZO (reports received by the Secretary of State).
• SI 2024/1368 (made on 16 December 2024, in force on 16 June 2025): reg 4 inserted Part 4A into UK MDR 2002.
• MHRA guidance: the MORE portal user guidance and the XML (XSD) format specifications for MIR and FSCA reports (according to public industry interpretation, MHRA has published XSD specifications for MIR and FSCA reports applicable to Great Britain).

3. Expert insights

Insight one: the channel is single and there is no alternative. Under MHRA’s vigilance system design, MORE is the unified entry point for vigilance reporting in both Great Britain and Northern Ireland. This means that account availability is compliance availability — an account not yet opened, permissions not yet configured, or templates not yet prepared will each directly produce an overdue submission. There is no fallback channel that preserves the deadline, and no provision for submitting by email as a stopgap.

Insight two: deadlines run from awareness, while portal operation needs lead time. The 2-day tier of reg 44ZH leaves an extremely short operating window. If the MORE account registration and the report template preparation have not been completed, submission within that window is practically impossible. The realistic conclusion is that the preparation work must be finished before the first incident ever arrives, because no amount of overtime compresses account approval and first-time template learning into two days.

Insight three: structured data formats have been standardised. MHRA has published XML (XSD) format specifications for MIR and FSCA reports, supporting structured submission. For companies with higher report volumes, integration through systems should be evaluated rather than filing each report manually by hand. Structured submission also improves data quality — mandatory fields are enforced at source, and resubmission after validation errors is faster than correcting a document-based filing.

Insight four: portal readiness has a supply-chain dimension. The account that submits a vigilance report belongs to the manufacturer, but the information that populates the report often originates with distributors, importers or the UKRP. If those partners do not know where to send a suspected incident within hours, the best-prepared portal account still receives nothing to submit. The training described above should therefore extend beyond the three internal interface functions to the external partners named in the distribution chain, with a written instruction on where and how quickly to route complaint information. As a practical estimate, the weakest link in most first submissions is not the portal itself but the delay between the incident occurring and the manufacturer becoming aware of it — and that delay is governed by partner awareness, not by the account.

4. Practical recommendations

GRZAN recommends treating MORE portal preparation as a pre-launch mandatory item rather than something completed after launch: before the device is actually placed on the market, complete the account application, configure user permissions, test-fill the report templates and perform one rehearsal submission. The rehearsal report should be run jointly with the UKRP, and the division of responsibilities between the manufacturer and the UKRP in the submission step should be defined in writing, so that no one is improvising a handover during a live incident. As a practical estimate, a first-time user should budget enough time for account validation, role assignment and at least one dry run of each report type that the portfolio may require — initial reports, final reports and FSCA notifications — because each has its own field set. The rehearsal should also confirm who holds the account credentials after hours and how a second person can submit if the primary operator is unavailable, since incidents rarely respect office hours. Finally, readiness should be re-verified periodically rather than assumed: an annual review covering account status, active users, template currency and the record of the last rehearsal keeps the preparation aligned with staff turnover and system changes, and gives the manufacturer documentary evidence of preparedness if MHRA ever examines how the deadlines were met.

5. Verification checklist

• □ MORE account has been applied for and activated
• □ Operator permissions have been configured
• □ MIR / FSCA report templates have been prepared
• □ At least one rehearsal submission has been completed
• □ The division of submission duties between the manufacturer and the UKRP has been agreed in writing

Regulatory information verified as of 29 October 2026.

• Appointment of the UK Responsible Person (UKRP) and support with signing the letter of authorisation
• Full-process MHRA registration (DORS) filing and account lifecycle management
• Device classification determination, GMDN code selection and annual registration fee calculation
• Dual-route design for Great Britain and Northern Ireland, including UK(NI) solutions
• Establishment of post-market surveillance (PMS) systems, preparation of PMSR/PSUR and submission of vigilance reports
• Emergency handling of serious adverse incidents and field safety corrective actions (FSCA)
• Monitoring of UK regulatory changes and compliance gap assessment

For post-market compliance support in the UK market — vigilance reporting, recall management and MHRA inspection response — contact GRZAN at info@grzanglobal.com.