Post-Market Surveillance (PMS) for Medical Devices

In the medical device industry, “PMS” refers to Post-Market Surveillance—continuous monitoring of medical device safety and performance after commercial release.

Regulatory Requirements

Under the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746, manufacturers must:

  • Proactively seek data about their devices after market release
  • Maintain a PMS plan identifying data sources and collection methods
  • Use PMS data to update technical documentation, risk management files, and instructions for use
  • Implement CAPAs (Corrective and Preventive Actions) based on surveillance findings

Manufacturer-Distributor Contract Requirements

Since distributors often serve as the sole contact point for customers, manufacturers must include specific PMS obligations in distribution agreements:

Essential Contractual Provisions:

Obligation CategorySpecific Requirements
Direct Data AccessProvide contact information for customers, sales reps, patients, and users; attend in-person meetings
Complaint HandlingImmediate communication to manufacturer; no distributor analysis of complaint data
Regulatory Authority CommunicationInform manufacturer of all communications; only provide written responses approved by manufacturer
CAPA SupportAssist with recalls, replacements, software updates, and chasing unresponsive customers
Sub-Distributor ComplianceFlow down all PMS obligations to any sub-distributors