MDR Articles 83-86
Under the MDR, post-market surveillance is a continuous system proportionate to the risk class. The reporting output differs by class - a PMS report for Class I, a periodic safety update report (PSUR) for higher classes.
| Class | Report | Frequency |
|---|---|---|
| Class I | Post-market surveillance report (Article 85) | Updated when necessary, made available on request |
| Class IIa | PSUR (Article 86) | When necessary and at least every two years |
| Class IIb | PSUR | At least annually |
| Class III and implantable devices | PSUR, submitted to the Notified Body through the electronic system | At least annually |
Post-market clinical follow-up (Annex XIV, Part B) proactively collects clinical data on the device in use, to confirm safety and performance, identify emerging risks and verify the benefit-risk ratio. It is planned in a PMCF plan and summarised in a PMCF evaluation report that updates the clinical evaluation. Where PMCF is not considered necessary, the justification must be documented.
PMS data feeds vigilance and trend reporting: serious incidents and field safety corrective actions are reported under Article 87, and statistically significant increases in non-serious incidents under Article 88.
At least annually for Class IIb and Class III devices, and when necessary and at least every two years for Class IIa devices.
No. Class I manufacturers prepare a post-market surveillance report under Article 85, updated when necessary.
PMCF is part of the post-market surveillance plan. If a manufacturer considers it not necessary, it must justify that in the plan.
Where PMS documents sit.
CER and PMCF strategy.
On getEAR.eu.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Check the consolidated text on EUR-Lex and the relevant MDCG guidance for your device. Last reviewed 30 September 2026.