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Post-Market Surveillance Requirements by Class

Overview​

All manufacturers are expected to conduct post-market surveillance (PMS) appropriate to the risk class of their device. The MDR does not prescribe a specific PMS methodology, but Health Canada expects a systematic, documented approach.

Class I​

Required: Basic QMS-based monitoring

  • Complaint handling and tracking
  • Distribution records
  • Reactively monitoring for safety signals
  • No proactive literature review required (but recommended for novel Class I devices)

Class II​

Required: Systematic complaint analysis and signal detection

  • Formal complaint handling system
  • Trend analysis of complaints and near-misses
  • Reactive literature review when safety signals emerge
  • Distribution records adequate to support recalls
  • Periodic internal review of PMS data

Class III​

Required: Active PMS programme

  • Proactive literature monitoring (systematic searches of published literature)
  • Vigilance database monitoring (MedEffect, FDA MAUDE, EU EUDAMED, TGA DAEN)
  • Formal complaint trend analysis
  • Periodic PMS reports reviewed by senior management
  • Post-Market Clinical Follow-Up (PMCF) plan (may or may not require additional data collection depending on available evidence)

Class IV​

Required: Comprehensive PMS with proactive clinical data collection

  • All Class III requirements, plus:
  • Active clinical follow-up (post-market studies, registries, or other structured data collection)
  • Periodic Safety Update Reports (PSURs) — see Periodic Safety Update Reports
  • Annual management review of PMS programme
  • Evidence-based updates to the risk management file based on PMS findings

Legislative source: Medical Devices Regulations, SOR/98-282; ISO 14971 (PMS as input to risk management); IMDRF PMS guidance