The IVDR expects manufacturers to actively monitor their devices once they are on the market, learn from real-world use, and act quickly when something goes wrong.
The post-market surveillance system
- PMS plan: how data will be collected and analyzed, including complaints, trends, literature, similar devices and user feedback
- Post-market performance follow-up (PMPF): proactive collection of performance data to confirm and update the performance evaluation
- PMS report (Class A and B): summary of results and actions, updated when necessary
- Periodic safety update report, PSUR (Class C and D): updated at least annually, with Class D PSURs reviewed by the notified body
Vigilance
Manufacturers must report serious incidents and field safety corrective actions to the competent authorities. Reporting deadlines are short:
| Situation | Report no later than |
|---|---|
| Serious public health threat | 2 days after becoming aware |
| Death or unanticipated serious deterioration in health | 10 days after becoming aware |
| Other serious incidents | 15 days after becoming aware |
Manufacturers must also report statistically significant increases in the frequency or severity of non-serious incidents or expected erroneous results (trend reporting), and issue field safety notices when corrective action is needed.
Making it work in practice
- Connect PMS directly to complaint handling, CAPA and risk management
- Make sure distributors report complaints quickly and completely
- Define clear criteria for when an erroneous result becomes a reportable incident
- Use PMS data to update the performance evaluation and labeling
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.