The UK’s post‑Brexit amendments to post‑market surveillance (PMS) bring new expectations—especially for the Periodic Safety Update Report (PSUR). Much remains aligned with EU MDR 2017/745, yet several additions and modifications demand attention from regulatory and quality teams.
Below, we outline the key UK‑specific changes—drawn entirely from the gap‑analysis PDF—and pair each with Morulaa Tips: practical pointers Morulaa’s MDR consultants use when updating PMS plans, procedures and reports.
Morulaa Tips: Expert MDR Advice for Updating Your PMS Plans and Reports
1. Device Identification: GMDN replaces EMDN
Under UK MDR the PSUR must list devices using GMDN codes, whereas EU MDR requires EMDN. Manufacturers must also note the first date of conformity for the GB market (CE‑mark or UKCA‑mark).
Morulaa Tip – Maintain a simple cross‑reference table of GMDN ↔︎ EMDN codes in your document‑control system. When you generate a UK PSUR, pull the GMDN list automatically to avoid manual errors.
2. Device Exposure and Demographic Data
- Volume of Sales: UK PSURs must state how many devices were supplied inside the UK (GB + NI) and worldwide.
- Usage Setting & Patient Profile: UK guidance adds examples—health‑care establishment, A&E, home use; patient age, gender, comorbidities, ethnicity—and stresses GDPR compliance.
Morulaa Tip – Tag each dispatch record with “market region” and configure your PMS database to export UK‑only volumes. Add optional fields in complaint and feedback forms that capture usage settings and anonymised demographics.
3. UK Vigilance Data and Trend Reporting
- Serious incidents must be shown separately for the UK and for the rest of the world.
- Trend reports now need explicit fields: device model, manufacturer reference number, date identified, date reported to MHRA, a brief description with thresholds, and status/CAPA linkages.
- FSCA summary must include a synopsis of FSCAs reported to MHRA in the period, plus links to any earlier FSCAs, and the MHRA report date.
Morulaa Tip – Adapt your vigilance database so each trend or FSCA record captures the extra UK fields at creation, not at Periodic Safety Update Report time. This shortens compilation time and ensures consistency.
4. Digital‑Health Metrics
UK PMS extends data collection to app downloads, user‑experience data, and connected digital‑health monitoring devices. These metrics should feed into incident analysis and benefit‑risk evaluation.
Morulaa Tip – Integrate analytics dashboards (e.g., Mixpanel, Firebase) with your post marketing surveillance workflow. Schedule monthly exports so app‑usage trends join vigilance data well before the PSUR drafting deadline.
5. Benefit‑Risk Conclusions and Data Validity
UK adds
- Discussion of any negative impact on overall benefit‑risk.
- A worked example of dataset limitations (e.g., pathogen variants outside validation sets) to illustrate data validity constraints.
- Confirmation that clinical risks remain within justified thresholds against state‑of‑the‑art alternatives, plus mention of new clinically meaningful benefits.
- Description of actions taken to reduce risks “as far as possible.”
Morulaa Tip – Add a short “Assumptions & Limitations” sub‑section in your Periodic Safety Update Report template. Populate it directly from your clinical‑evaluation plan and risk‑management file so every limitation is tracked and addressed.
6. Updating PMS Plans, Procedures and Reports
UK‑Specific Requirement | Document(s) to Update | Morulaa Tip for Implementation |
GMDN coding | PMS Plan, PSUR template | Maintain GMDN/EMDN mapping sheet under document control. |
UK sales segmentation | Vigilance SOP, PSUR data‑pull script | Embed region tags in ERP/CRM export routines. |
Trend report data fields | Vigilance form, CAPA log | Add mandatory fields at incident‑logging stage. |
FSCA cross‑referencing | FSCA register, PSUR template | Use unique FSCA IDs and link them in each new PSUR. |
Digital‑health analytics | PMS Plan, Data‑collection SOP | Automate monthly export of app‑usage stats. |
Benefit‑risk narrative | Risk‑management SOP, PSUR template | Create a table that cross‑references risks with state‑of‑the‑art comparators. |
Key Takeaway
The UK PSUR framework retains European medical device regulation’s backbone but introduces new layers of granularity—regional data splits, digital‑health metrics, and fully mapped corrective actions.
By integrating the Morulaa Tips above into your PMS processes, you can meet MHRA expectations without rebuilding your entire system.
If your team needs a second set of eyes on revised PMS procedures or a peer review of UK‑ready PSURs, Morulaa is happy to help— whether it is through targeted gap‑analysis or hands‑on document updates.