Periodic Reporting in Great Britain: PMSR, PSUR and Trend Reports

1. Key takeaways

Part 4A establishes three classes of periodic reporting obligations. The PMS report (reg 44ZL) applies to Class I devices and to IVDs that do not fall within the PSUR categories: the first report must be prepared within 3 years of placing the device on the market, and thereafter updated at least every 3 years. The PSUR (reg 44ZM) applies to Class IIa devices (every 2 years, with the first report within 2 years), to Class IIb and Class III devices (every 1 year, with the first report within 1 year), and to IVDs listed in Annex II List A and List B, as well as IVDs of Class C and D under the EU IVDR (annually). Trend reporting (reg 44ZN) is a separate, standalone obligation addressing situations in which non-serious incidents or expected side effects show a statistically significant increase in frequency or severity.

Taken together, the three obligations mean that reporting workload in Great Britain is a direct function of classification. A single product family spanning Class I, Class IIa and Class IIb devices can carry three different reporting rhythms simultaneously, and each rhythm starts from the date the device was placed on the market. The obligations also interact with the vigilance rules: an incident that triggers an initial report under reg 44ZH will usually also feed the benefit-risk analysis in the next PSUR, so the periodic report cannot be drafted as an isolated exercise detached from the complaint file.

2. Legal basis

• UK MDR 2002 (SI 2002/618, as amended): reg 44ZL (PMS report), reg 44ZM (PSUR), reg 44ZN (trend reporting) and reg 44ZR (production of documents on request, within 3 working days).
• SI 2024/1368 (made on 16 December 2024, in force on 16 June 2025): reg 4 inserted Part 4A into UK MDR 2002.
• Classification basis: reg 7 (general device classification rules) and Directive 98/79/EC Annex II (IVD List A / List B, as amended by Schedule 2A).

3. Expert insights

Insight one: the dividing line between PMSR and PSUR is classification. This dividing line means that the classification determination directly decides the annual compliance workload. A device determined to be Class IIa rather than Class I moves from a 3-year reporting cycle to a 2-year cycle, and its report format upgrades from a PMS report to a PSUR — which is precisely the practical reason why classification must be determined rigorously. Because the UK applies its own classification rules rather than EU conclusions, a portfolio review should be repeated for Great Britain even where the EU classification has long been settled.

Insight two: the addressee of a PSUR includes the UK approved body. Where there is a UK approved body, the PSUR must be submitted to that body; in addition, a PMS report or PSUR must be provided to MHRA within 3 working days of a request (reg 44ZR). This means a PSUR is not a document that is prepared, filed and archived, but one that must be retrievable at any time. The retention system therefore has to guarantee that any current report can be located and produced within that window, whatever the size of the portfolio.

Insight three: the trend reporting threshold must be predefined in the PMS plan. reg 44ZN targets a statistically significant increase in the frequency or severity of non-serious incidents or expected side effects, where that increase could affect the benefit-risk analysis. If the PMS plan does not define the thresholds and the assessment method in advance, this obligation cannot be discharged in practice — there is nothing to compare a rise against. The definition should state the data sources, the observation window and the statistical method so the analysis is reproducible.

Insight four: MHRA has published a standard format for PMS reports. According to official and industry interpretation, MHRA has published a standardised format for PMS reports; documents prepared for other notified bodies in a different format may need to be reworked before they can be submitted to MHRA. Planning for this reformatting in advance avoids a scramble when the first deadline arrives.

4. Practical recommendations

GRZAN recommends establishing a reporting calendar: using each product’s classification and first date of placing on the market as inputs, the calendar automatically generates the first and subsequent due dates for the PMS report or PSUR, with a start reminder set 90 days ahead of each due date. At the same time, the statistical method and trigger thresholds for trend reporting should be defined explicitly in the PMS plan, and that plan should be filed together with the reporting calendar with the UKRP, so that the whole reporting apparatus is documented in one place. As a practical estimate, the calendar is most robust when it is owned by a single named role, reviewed at each classification change, and reconciled quarterly against the actual submission record, because reporting dates drift whenever products are reclassified, renamed or transferred between legal entities. Late-start products should be added to the calendar at the moment of first shipment, not at the end of the year.

5. Verification checklist

• □ For each product, the applicable PMS report or PSUR has been determined by classification
• □ The reporting calendar includes first and subsequent due dates
• □ A start reminder has been set 90 days ahead of each due date
• □ The statistical method and thresholds for trend reporting have been defined in the PMS plan
• □ PSURs have been submitted to the UK approved body where required

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.