Description:
This PMS Plan defines how we will proactively and systematically collect, analyse, and act on post-market data for devices in scope.

• Define the PMS Scope (device range and data collection period)

• Ensure compliance with MDR Article 84 and Annex XIV, aligned with MDCG 2022-21

• Capture manufacturer, Authorised Representative, Notified Body, and competent authority PMS details

• Document device regulatory status in Europe, including Basic UDI-DI / EUDAMED DI and market/FSCA status

• Specify labelling essentials: Intended purpose, Indications, Contra-indications, Target populations

• Set risk-based threshold values and indicators linked to ISO 14971 risk management files

• Define trend analysis rules (including significance triggers) and escalation via MDR Article 88

• Plan PMS activities and outputs feeding PMS Report / PSUR and the wider technical documentation

Your needs:

• Post-market surveillance plan

• Post-market surveillance plan for MDR decision-making

• Reduce audit risk, strengthen benefit-risk control, and speed up PSUR readiness

This document is used to plan and govern PMS across the full device lifecycle, including data sources, responsibilities, and reporting cadence under MDR Article 84 and Annex XIV.

It covers the key PMS requirements end-to-end. Threshold values are predefined risk-based limits used to judge when post-market signals may affect benefit-risk; they matter because they trigger justified escalation. Trend reporting is the structured detection and evaluation of statistically relevant increases; it matters because it can drive CAPA and competent authority notifications.

• Define incident capture for serious and non-serious events using IMDRF coding

• Document FSCA and CAPA tracking and reconciliation versus prior periods

• Ensure PMCF interfaces via the PMCF plan and evaluation reporting

• Define literature, public database, registry, and similar-device monitoring expectations

• Specify PSUR/PMS report frequency and integration into RMF, CER, and Annex III technical documentation

At Lexqara, we tailor your PMS Plan to your device portfolio, verify the MDR logic for grouping and reporting, and help you implement practical PMS/PMCF workflows that stand up in audits. Access templates in our Resource Center and see our Post-Market Activities support. For the legal baseline, use EU MDR (Regulation (EU) 2017/745). Download the template or request a short gap assessment.

A strong PMS Plan also clarifies timelines (collection, analysis, submission), ensures consistent data granularity by device/model, and prevents gaps between complaints handling, risk management updates, and clinical documentation updates.