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Periodic Safety Update Reports (PSURs)

Overview​

A Periodic Safety Update Report (PSUR) is a periodic document that consolidates all post-market safety and effectiveness data for a device, evaluates the ongoing benefit-risk profile, and draws conclusions about whether any regulatory action is needed.

PSURs are not currently mandated by the Medical Devices Regulations for all devices, but Health Canada recommends them for Class III and Class IV devices and may request them during a compliance review or licence amendment process. Health Canada follows IMDRF guidance on PSURs.

ClassRecommended frequency
Class IVAnnually until evidence base is well-established; then every 2–3 years
Class IIIEvery 2–3 years
Class II (selected high-risk)As indicated by PMS findings

PSUR content​

A PSUR should include:

  1. Device identification — name, licence number, models covered
  2. Reference to technical documentation — current risk management file, labelling
  3. PMS data — summary of all post-market data collected (complaints, vigilance events, literature, registries)
  4. Safety analysis — updated benefit-risk analysis based on PMS data
  5. Conclusions — whether the benefit-risk profile remains acceptable
  6. Action plan — any corrective actions triggered by the PMS data

Relationship to Device Licence amendments​

If a PSUR concludes that a Device Licence amendment is needed (e.g., a new contraindication, a labelling update), the amendment process must be initiated promptly. See Amending a Device Licence.

Reference: IMDRF MDCE WG/N56FINAL:2019 (Periodic Safety Update Report for Medical Devices)