Post-Market Surveillance (PMS Plan)

MDR Reference: Annex III; Article 83-85
BPG Rev.4 Reference: Section 7 (pp. 87-92)
Document Code: AIII-PMS
Responsible Party: CRO
Service Mode: Write / Assist

PMS Plan

Requirements Checklist (per Annex III, 1.1)

Scope & Device Identification

• [ ] Device or device group covered by the plan clearly defined
• [ ] Basic UDI-DI(s) and variants identified
• [ ] For grouped devices: justification for grouping relevance
• [ ] PMS activities proportionate to device risk class

Data Sources (Annex III 1.1(a)) -- Reactive & Proactive

Reactive sources (passive data collection):

• [ ] Customer complaints and feedback
• [ ] Trend reports from complaints
• [ ] Returned product analysis
• [ ] Vigilance reports (FSCAs, FSNs)

Proactive sources (active data collection):

• [ ] Literature monitoring (systematic, ongoing)
• [ ] Regulatory database monitoring (EUDAMED, MAUDE, MHRA, BfArM, etc.)
• [ ] Registries (national/international)
• [ ] User surveys and feedback programs
• [ ] Peer-reviewed scientific articles
• [ ] Trade press and social media monitoring

Plan Content Requirements (Annex III 1.1(b))

• [ ] Methods and processes to collect and utilise data on:
  • [ ] Serious incidents and FSCAs
  • [ ] Non-serious incidents and undesirable side effects
  • [ ] Trend reporting
  • [ ] Relevant specialist/technical literature, databases, registries
  • [ ] Feedback and complaints from users, distributors, importers
  • [ ] Publicly available vigilance data on similar devices
• [ ] Effective and appropriate methods to assess collected data
• [ ] Suitable indicators (Key Performance Indicators) and related threshold values
  • [ ] Thresholds linked to risk management outputs and clinical evaluation
  • [ ] Re-evaluation actions when thresholds exceeded
• [ ] Methods and protocols for managing events subject to trend report (Article 88)
• [ ] Methods and protocols for communication with CAs, NBs, economic operators
• [ ] Reference to procedures for preventive/corrective actions and verification of effectiveness
• [ ] Methods to act on feedback from PMS activities (action response from PMS Plan to RMF/CE)
• [ ] Actions to improve device usability, performance, safety
• [ ] Systematic procedure to detect misuse or off-label use and evaluate significance
• [ ] Effective feedback loop between PMS, risk management, and clinical evaluation

Integration with Risk Management

• [ ] PMS objectives driven by residual risks from clinical evaluation
• [ ] PMS activities linked to specific risks in risk management file
• [ ] Justification for risks not requiring additional PMS activities
• [ ] Reference to ISO/TR 20416:2020 for PMS plan scoping

PMS Report (Class I devices, Article 85)

• [ ] Results and conclusions of PMS data analysis
• [ ] Updated as necessary
• [ ] Available to competent authorities upon request

Key Regulatory References

• MDR (EU) 2017/745, Annex III (PMS documentation)
• MDR (EU) 2017/745, Article 83 (PMS system)
• MDR (EU) 2017/745, Article 84 (PMS plan)
• MDR (EU) 2017/745, Article 85 (PMS report for Class I)
• MDR (EU) 2017/745, Article 88 (Trend reporting)
• ISO/TR 20416:2020: Medical devices -- PMS for manufacturers
• MDCG 2020-7: PMCF plan template (PMS integration)
• MDCG 2022-21: PSUR guidance
• Team-NB BPG for TD Submission, Rev.4 (2026-04-21), Section 7

Common Pitfalls (from BPG Rev.4)

• PMS plan not specific to device type (generic QMS-level only)
• Level of detail insufficient or incomplete against Annex III 1.1(b)
• PMS activities not proportionate to device risk
• Indicators and threshold values not linked to risk management outputs
• No clear criteria for re-evaluation when thresholds exceeded
• Complaint handling not systematic or not feeding back into risk management
• Proactive data collection limited to complaint handling only (missing systematic literature review, database monitoring)
• Feedback loop between PMS, RM, and CE not demonstrated

Dependency

PMS Plan is a Phase 3 deliverable:

• Depends on CER (clinical evidence gaps drive PMS indicators)
• Depends on RMR (residual risks drive PMS objectives)
• Feeds into PSUR (data collection per plan generates PSUR content)
• Feeds back into RMR and CER updates (lifecycle approach)