MDR Article 83-86
Post-Market Surveillance & PMCF
Stay compliant after CE marking. We build the PMS system that keeps your certificate alive.
Why it matters
PMS is the #1 source of MDR non-conformities at surveillance audits. A weak PMS Plan or missing PMCF Report can suspend your CE certificate within weeks.
Deliverables
- PMS Plan (MDR Annex III)
- PMS Report / PSUR (Class I / IIa / IIb / III)
- PMCF Plan (MDCG 2020-7)
- PMCF Evaluation Report (MDCG 2020-8)
- Trend reporting & vigilance procedures
- Field Safety Corrective Action (FSCA) support
- Complaint handling SOP integration
- Eudamed PMS module preparation
Frequently Asked Questions
Class IIa: every 2 years. Class IIb & III: annually. Class I: PMS Report (no formal PSUR), update as needed.