Post-Market Compliance — Protecting Your CE Mark
Under EU MDR 2017/745, Post-Market Surveillance is no longer an afterthought — it is a continuous, mandatory regulatory programme. RABT Global manages your complete PMS programme, from PMS plan and PMSR reporting to vigilance, FSCA, and PMCF — protecting your CE mark and your market access.
Find out how RABT Global can take over your EU MDR post-market compliance obligations — as a managed retainer service or project-by-project.
Post-Market Surveillance Under EU MDR — What You Must Do
Under EU MDR 2017/745, manufacturers must establish, implement, document, and maintain a Post-Market Surveillance system for each device. This is a legal obligation — not optional — and must be integrated with your risk management file and clinical evaluation.
⚠ Under MDD, PMS was largely reactive. Under EU MDR, it is proactive and continuous.
EU MDR Article 83 requires manufacturers to actively collect and review:
- Serious complaints and adverse events
- Vigilance data from EUDAMED
- Feedback from users, distributors, and importers
- Publicly available data from similar devices
- Published literature on equivalent technologies
- Post-Market Clinical Follow-Up (PMCF) study data
Failure to maintain an adequate PMS system can result in Notified Body certificate suspension, competent authority enforcement action, or market withdrawal.
PMS, PMCF, and PSUR — What’s the Difference?
| PMS — Post-Market Surveillance | PMCF — Post-Market Clinical Follow-Up | PSUR — Periodic Safety Update Report |
| The overarching system for collecting, recording, and analysing data on your device in the post-market phase — covering safety, performance, and emerging risks. | A subset of PMS focused specifically on collecting CLINICAL data post-market — through systematic literature reviews, PMCF studies, device registries, or structured patient follow-up. | A periodic benefit-risk assessment that integrates all PMS and PMCF data — required for Class IIa (every 2 years), Class IIb (every 2 years), and Class III (annually). |
| Required for: All devices — Class I to III. | Required for: All devices — PMCF plan mandatory; scope and depth varies by class and CER conclusions. | Required for: Class IIa, IIb, and III. |
| Key document: Post-Market Surveillance Report (PMSR) or Periodic Safety Update Report (PSUR) depending on class. | Key document: PMCF Plan + PMCF Report (periodic updates to CER). | Key document: PSUR submitted to Notified Body and held in technical documentation. |
Our Post-Market Surveillance Services — Full Scope
PMS Plan Development
device-specific PMS plan to EU MDR Annex III Part B requirements, integrated with risk management and CER
Post-Market Surveillance Report (PMSR)
annual PMSR for Class I and IIa devices — summarising PMS activities, findings, and actions
Periodic Safety Update Report (PSUR)
annual (Class III) or biennial (Class IIa/IIb) benefit-risk assessment report for Notified Body
Vigilance Reporting
serious incident identification, reporting to competent authorities via EUDAMED within regulatory timelines
Field Safety Corrective Action (FSCA) Management
FSCA strategy, Field Safety Notice (FSN) preparation, regulatory authority notification, and user communication
Complaint Handling System Support
complaint classification procedure, trend analysis, and signal detection aligned with EU MDR requirements
PMCF Programme Management
PMCF plan execution, literature review updates, registry study management, and PMCF report preparation
PMS Retainer Service
ongoing managed PMS compliance as a retainer — our team acts as your outsourced PMS department
Post-Market Surveillance — FAQs
A: A serious incident under EU MDR Article 87 is any malfunction or deterioration in the characteristics or performance of a device that has led to, or might have led to: death of a patient or user; serious deterioration in health; or serious public health threat. If causality cannot be excluded, the incident must be reported. RABT Global’s vigilance consulting advises on incident classification and reporting obligations.
A: Not always — but a PMCF plan is mandatory for all devices. The nature and extent of PMCF activities depend on the device class, the strength of pre-market clinical evidence, and gaps identified in the CER. For devices with strong pre-market clinical data, PMCF may consist of systematic literature review and analysis of post-market complaint data. For novel or higher-risk devices, formal PMCF studies or registries are typically required.
A: Our PMS retainer provides outsourced, managed post-market surveillance for your device portfolio. We assign a dedicated PMS specialist to your account, monitor EUDAMED and regulatory intelligence, collect and analyse PMS data, prepare all required reports (PMSR/PSUR), manage vigilance obligations, and coordinate PMCF activities — acting as your outsourced PMS department at a predictable annual cost.
A: A Post-Market Surveillance Report (PMSR) is required for Class I and Class IIa devices — a summary of PMS activities and findings, without the formal benefit-risk reassessment structure. A Periodic Safety Update Report (PSUR) is required for Class IIb (at least every 2 years) and Class III (annually) — a more formal benefit-risk reassessment that integrates all PMS, PMCF, and clinical data and must be submitted to the Notified Body.
Protect Your CE Mark with a Managed PMS Programme
RABT Global’s Post-Market Surveillance services keep your EU MDR compliance current — PMSR, PSUR, vigilance, FSCA, and PMCF — all managed by our specialist PMS team.