In the Vigilance module of EUDAMED, manufacturers, importers, and authorized representatives will be required to upload their Post-Market Surveillance (PMS) reports. For notified bodies and competent authorities, it will also become relevant for their Market Surveillance reports. As of now, mandatory use of the MDR Vigilance module is planned for July 2026. However, due to the delayed finalization of the UDI module, meeting this deadline appears unlikely. Regardless, good preparation can save a lot of stress.
A good starting point for preparation is this article. Here, we explain the basic terms related to the EUDAMED Vigilance module. What is the difference between Market Surveillance and Post-Market Surveillance? What do I need to know about the Vigilance system? Which reports must be uploaded to EUDAMED and when? These and other questions are answered here.
Post-Market Surveillance
During the PMS process, manufacturers are required to actively seek information about their products. This information should help ensure or even improve the safety and performance of the medical device. To meet the PMS requirements under the MDR, manufacturers must establish a PMS plan and a PMS system for each product.
PMS Plan
The goal of a PMS plan is to ensure that everyone involved within the company knows what to do, when, and how. You can think of it as a to-do list for those responsible for Post-Market Surveillance. It helps achieve the objectives of post-market monitoring, with a primary focus on product safety, patient protection, and regulatory compliance. The PMS plan essentially defines how the market must be monitored and what actions are necessary to ensure the safety of each product.
The PMS plan forms the basis of the PMS system and is part of the product’s technical documentation.
PMS System
A PMS system must ensure the proactive and systematic collection and analysis of data. It enables the definition, implementation, and monitoring of preventive or corrective actions for a product.
The PMS system is based on the PMS plan. It is part of the internal quality management system and must be defined for each product. The required measures depend on the risk class and product type.
The PMS system is used for:
- Updating/improving risk management
- Identifying preventive, corrective, or safety-related corrective actions
- Updating design, instructions for use, and labelling
- Identifying opportunities to improve usability, performance, and safety
- Updating the clinical evaluation
- Contributing to PMS of other products
- Updating the Summary of Safety and Clinical Performance (SSCP)
- Detecting and reporting trends
Vigilance
Unlike Post-Market Surveillance, Vigilance under the MDR is a reactive system for handling incidents. A manufacturer’s Vigilance system defines how incidents and significant corrective actions (i.e. Field Safety Corrective Actions – FSCA) are managed. Vigilance in the MDR is a key component of the manufacturer’s PMS system.
There are several conditions and associated reports that a manufacturer must consider and potentially submit:
MIR – Manufacturer Incident Report
FSCA – Field Safety Corrective Action
FSN – Field Safety Notice
PSR – Periodic Summary Report
PSRP – PSR Update Analysis Report
MTR – Manufacturer Trend Report
All reports must be submitted via EUDAMED. These obligations apply regardless of the product’s risk class or type. If the conditions for a report are met, the manufacturer must act.
Market Surveillance
Articles 93 to 100 of the MDR define the requirements for Market Surveillance. This is carried out by competent authorities and notified bodies—not by economic operators. The goal is also to ensure the safety and performance of products after they have been placed on the market. Authorities are required to conduct regular, risk-based inspections, which may be announced or unannounced. These inspections may include documentation reviews, physical product checks, and laboratory analyses.
Authorities also create annual surveillance plans, which are uploaded to the Market Surveillance module of EUDAMED and made publicly accessible. If risks are identified, products may be seized or destroyed.
Post-Market Surveillance Reports
Two types of reports are essential for PMS:
- Post-Market Surveillance Report (PMS Report)
- Periodic Safety Update Report (PSUR)
PMS Report
According to Article 85 of the MDR, manufacturers of Class I devices must summarize the results and conclusions of the data analyzed from their PMS activities in a PMS report. This report must include a justification and description of any preventive and corrective actions taken.
The creation of the report is mandatory under the MDR, but updates are only required as needed. The report remains within the manufacturer’s system but must be provided to the competent authority upon request.
PSUR
Article 86 of the MDR requires manufacturers of Class IIa, IIb, and III devices to prepare a PSUR for each product throughout its entire lifecycle.
The PSUR summarizes the results and conclusions of the data analyzed from PMS activities and must include:
- Justification and description of preventive and corrective actions
- Conclusions of the benefit-risk determination
- Key findings from post-market clinical follow-up (PMCF)
- Sales volume and estimated size (and other characteristics) of the population using the device, and, if possible, frequency of use
| Risk Class | Implantable? | Regular Updates | Part of Technical Documentation? | Report Upload Target |
|---|---|---|---|---|
| IIa | No | At least every 2 years | Yes | EUDAMED |
| IIb | No | At least annually | Yes | None (NB and CA upon request) |
| IIb | Yes | At least annually | Yes | EUDAMED |
| III | Yes and no | At least annually | Yes | EUDAMED |
The MDR has significantly tightened the requirements for Post-Market Surveillance, Vigilance, and Market Surveillance. Manufacturers, notified bodies, and competent authorities are now more accountable for ensuring transparency for patients. This includes linking uploaded reports to the correct UDI data. Just as the product master data is due in Q1 2026, it is advisable to start preparing for the Vigilance module early.