GB PMSR/PSUR Dual Reporting for EU and UK Medical Devices

What This Article Covers / Does Not Cover

This article covers one operational challenge: how to structure your Periodic Safety Update Reports (PSURs) and Post-Market Surveillance Reports (PMSRs) so that a single reporting process satisfies both EU MDR/IVDR requirements and Great Britain's new PMS requirements under SI 2024/1368 (effective 16 June 2025). It provides a side-by-side comparison of both regimes, a unified report template, data-period alignment strategy, GB-specific content sections, and the practical workflow for dual submission.

This article does not cover the fundamentals of PMS planning, PSUR writing methodology, or EU MDR PMS requirements in isolation. For the broader PMS framework, see Post-Market Surveillance Guide. For PSUR writing, see PSUR Periodic Safety Update Report Guide. For UK regulatory requirements, see UK MHRA UKCA Regulation Guide.

Regulatory Background

Great Britain: SI 2024/1368

The UK's Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368) came into force on 16 June 2025. It inserts a new Part 4A into the UK Medical Devices Regulations 2002, establishing PMS obligations for all devices placed on the market or put into service in Great Britain — including CE-marked devices certified under EU MDR/IVDR.

Key Differences: EU MDR vs GB SI 2024/1368

Dual-Report Architecture: Three Options

Option Comparison

Recommendation

For most manufacturers, Option A (Unified PSUR with GB Annex) is the most efficient. BSI, the largest UK Approved Body, has confirmed that clients should upload a single PSUR that meets both regulations to the BSI Client Portal, using a cover page to identify which regulations, devices, and data periods are covered.

Unified PSUR Template (Option A)

Report Structure

Data-Period Alignment Strategy

Challenge

EU PSURs are updated on a rolling basis from the date the device is placed on the EU market. GB PSURs are due within 1 year (Class IIb/III) or 2 years (Class IIa) of the device being placed on the GB market after 16 June 2025 — or within the same period from 16 June 2025 for devices already on the market.

Alignment Decision Tree

Q1: Was the device first placed on the EU market
    before 16 June 2025?
    ├── YES → Q2
    └── NO (launched after 16 June 2025) → Q3

Q2: Was the device already registered with MHRA
    and sold in GB before 16 June 2025?
    ├── YES → GB PSUR data period starts 16 June 2025
    │         (saving provision in SI 2024/1368)
    │         Align EU data period to include this date
    │         if possible
    └── NO → GB PSUR data period starts from GB placement date

Q3: Launch dates in EU and GB are close together?
    ├── YES → Use a single data period covering both markets
    └── NO → Overlapping data periods; extract GB data
              from shared PMS database for GB-specific sections

Data-Period Alignment Table

GB-Specific Content Requirements in Detail

1. Sales/Exposure Data Breakdown

Per MHRA PSUR standardized format (June 2025):

2. Incident Coding

GB requires IMDRF Adverse Event Terminology (AET) coding:

3. Patient and Public Engagement

SI 2024/1368 regulation 44ZF(3)(v) requires the PMS plan to consider user experience through patient and public engagement "if appropriate." Document:

4. Record Retention

FSCA Linkage Across Both Regimes

FSCA Dual-Notification Workflow

FSCA Identified
      │
      ├── EU Notification
      │     ├── Notify NB via EUDAMED (if applicable)
      │     ├── Submit FSN to national competent authorities
      │     └── Document in EU PSUR
      │
      ├── GB Notification
      │     ├── Submit FSN to MHRA via MORE portal
      │     ├── Use MHRA FSN template
      │     ├── Report to UK Responsible Person
      │     └── Document in GB PSUR section
      │
      └── Cross-Reference
            ├── Link FSCA reference numbers (EU + GB)
            ├── Confirm scope alignment (same devices affected?)
            └── Ensure corrective action timeline meets
                both EU and GB requirements

FSCA Summary Table for Dual PSUR

Practical Workflow: Building the Dual PSUR

Step-by-Step Process

Common Failure Modes and How to Remediate

What Goes in the File

Document Index for Dual PMS System

RACI for Dual PSUR Production

Key Regulatory References

Pre-Submission Checklist: Dual PSUR Review

• Data period covers both EU and GB requirements (check GB saving provisions for devices on market before 16 June 2025)

• Cover page identifies both MDR/IVDR and SI 2024/1368 as applicable regulations

• NB certificate numbers and AB certificate numbers listed on cover page

• Sales data broken down into EU, GB, NI, and worldwide per MHRA template

• GB serious incidents coded with IMDRF AET Annex D and F codes

• Expected side-effects are included in GB section (no exclusion per GB rules)

• Trend reporting assessed against GB "significant adverse impact on risk analysis" threshold

• FSCA table includes both EU and GB/MORE reference numbers

• Patient/public engagement findings documented in GB section

• GB retention period (10 or 15 years) confirmed and documented

• PSUR bundling criteria verified for GB (same CER/PER, similar devices)

• UK Responsible Person identified and copied on submission

• PSUR uploaded to both NB portal and AB portal

• Record ready for MHRA submission upon request

• IMDRF coding verified against MHRA standardized format examples

• Internal review completed by medical, QA, and legal