Vigilance Under the EU MDR - Legal Foundations and Practical Application
This course provides a structured and practice oriented introduction to vigilance requirements under the EU MDR. Participants learn how to evaluate market feedback, determine reporting obligations, and implement appropriate corrective and preventive actions. The training explains the legal foundations of vigilance, the roles of economic operators, and the interaction between PMS, incident reporting, and field safety corrective actions. Real world examples and workshop elements help participants build confidence in applying vigilance processes and communicating effectively with authorities and Notified Bodies.
Course Outline
- PMS and vigilance definitions, terminology, and regulatory context
- Roles and responsibilities of manufacturers and economic operators
- MIR, MIN, FSCA, and FSN processes and templates
- Reporting timelines, thresholds, and documentation
- Communication strategies with authorities and Notified Bodies
- Comparison of EU MDR and FDA vigilance requirements
- Practical examples, workshops, and real world case studies
Learning Outcomes
Introduction to PMS and Vigilance
- Definitions and terminology
- Overview of EN ISO 13485 and MDR/IVDR vigilance requirements
- Roles and responsibilities of economic operators
Reporting Obligations and Timelines
- Incident reporting (MIR)
- Trend reporting and vigilance thresholds
- Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN)
- Mandatory timelines and required documentation
Templates and Practical Application
- Structure and use of:
- MIR (Manufacturer Incident Report)
- MIN (Manufacturer Incident Notification)
- FSCA templates
- Hands on exercises for incident reporting
- Workshops on MIR and FSCA decision making
Communication and Regulatory Interaction
- Effective communication with Notified Bodies and competent authorities
- Managing follow up questions and corrective action requests
- Documentation requirements within the QMS
Comparison: EU MDR vs. FDA Requirements
- Key similarities and differences
- Practical implications for global manufacturers
Who Should Attend
Who Should Attend
- Medical device manufacturers
- Regulatory Affairs professionals
- Quality Management teams
- Post Market Surveillance specialists
- Persons Responsible for Regulatory Compliance (PRRC)
- Marketing teams involved in feedback collection
- Service providers
- Other economic operators (distributors, importers, etc.)
Why You Should Attend
This course is ideal for professionals responsible for post market activities and regulatory compliance. It equips participants to identify and evaluate real world feedback, determine reporting obligations, and implement effective vigilance actions. Practical exercises and case studies help translate regulatory requirements into confident, well structured decision making and communication with authorities.
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