Under the MDR, a device is never “done”. Post-market surveillance turns the CE mark into an ongoing obligation to prove — continuously — that the device remains safe and effective in real-world use.
Every manufacturer must run a post-market surveillance (PMS) system under Article 83, planned per Article 84 and Annex III. The outputs depend on class.
PMS reports and PSURs
- Class I devices produce a PMS Report, updated when necessary.
- Class IIa, IIb and III produce a Periodic Safety Update Report (PSUR).
PSUR frequency: Class III and IIb at least annually; Class IIa at least every two years. For Class III and implantables, the PSUR goes to the notified body and is made available to authorities.
PMCF: the proactive arm
Post-Market Clinical Follow-up continuously gathers clinical data on the CE-marked device to confirm its safety, performance and benefit-risk balance. Its findings feed the clinical evaluation report and the PSUR — closing the loop between market experience and the technical file.
Vigilance: the reporting clock
Serious incidents must be reported under Article 87 within strict deadlines:
- Serious public-health threat: immediately, no later than 2 days after awareness.
- Death or unanticipated serious deterioration in health: no later than 10 days.
- Other serious incidents: no later than 15 days.
Manufacturers also report field safety corrective actions and, under Article 88, any statistically significant increase in the frequency or severity of non-serious incidents — trend reporting.
Flowing into EUDAMED
These processes ultimately report through EUDAMED. Its vigilance module is not yet mandatory, so incident reporting currently continues via national channels and the manufacturer incident report form — but the direction is toward a single European system.
How PQRA helps
PQRA sets up and runs PMS systems, PSURs, PMCF and vigilance reporting so post-market obligations are met on time, every time.
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