What are the MDR post-market surveillance requirements?
MDR Article 83–86 · Annex III · Article 87 (vigilance)
The short answer
Article 83 MDR requires manufacturers to establish a proactive, systematic post-market surveillance system for every CE-marked device. PMS is not just complaint handling — it is an ongoing process of collecting, analysing, and acting on clinical and technical data gathered after market placement. Class IIa/IIb/III must produce Periodic Safety Update Reports (PSURs); Class I produces a PMS Report.
PMS system components
- PMS Plan (Annex III): Describes methods, frequency, and responsibilities for post-market data collection and analysis
- Complaint handling: Systematic recording, investigation, and trending of all device complaints
- Vigilance: Reporting of serious incidents and field safety corrective actions (FSCAs) to competent authorities
- Literature surveillance: Systematic monitoring of scientific literature for safety and performance signals
- Registry data: National and disease registries, where relevant to the device type
- PMCF data: Proactive post-market clinical follow-up activities
- Data analysis and reporting: Findings feed into PSUR or PMS Report and update CER, risk management file, and GSPR
PSUR requirements by class
| Device class | Document required | Update frequency |
|---|---|---|
| Class III / Class IIb | Periodic Safety Update Report (PSUR) | Annually |
| Class IIa | Periodic Safety Update Report (PSUR) | At least every 2 years |
| Class I | PMS Report (shorter; no NB submission) | When updated; no fixed statutory cycle |
The PSUR must summarise conclusions of the benefit-risk determination, main findings of the PMS, the volume of sales and an estimate of the exposed population, and the current state of the clinical evaluation. It is submitted to the NB and made available to competent authorities.
Vigilance — serious incidents and FSCAs
Manufacturers must report to the competent authority of the member state where the incident occurred:
- Immediately (2 days): Incidents that are serious and life-threatening or have led to death; or public health threats
- Within 15 days: Other serious incidents
- Within 30 days: FSCA (Field Safety Corrective Action) implementation notification
A serious incident is an incident that directly or indirectly led to, could have led to, or could lead to the death or serious deterioration of health of a patient, user, or other person. Near-misses and potential serious incidents are also in scope.
Post-Market Clinical Follow-Up (PMCF)
PMCF is the proactive collection of clinical data after market placement. It is distinct from reactive surveillance and complaint handling.
- PMCF Plan: Part of the clinical evaluation; describes activities (surveys, registries, observational studies, literature studies)
- PMCF Report: Documents results of PMCF activities; feeds back into the CER update cycle
- For Class III/implantable IIb: NB reviews PMCF plan; deviations require justification
Frequently asked questions
What is the difference between a PMS Report and a PSUR?
Both summarise post-market surveillance findings. The PSUR is required for Class IIa/IIb/III, is submitted to the NB, and has specific content requirements under Article 85/86. The PMS Report is required for Class I, is lighter in content, and is not submitted to a NB.
Does complaint handling qualify as PMS?
Complaint handling is one component of PMS, but MDR PMS goes beyond reactive complaint handling. It requires proactive literature surveillance, PMCF, and registry data monitoring. Relying solely on complaints would not satisfy the Article 83 system requirements.
What is MDR trend reporting?
Article 88 requires manufacturers to report statistical trends in non-serious incidents or expected undesirable side effects that could represent a signal. Trend reporting is distinct from vigilance reporting of individual serious incidents.