What Is Vigilance in the Context of MDR and IVDR?
Vigilance refers to a post-market surveillance system for monitoring the safety of medical devices and IVDs once they are placed on the market. It involves detecting, analyzing, reporting, and documenting serious incidents and implementing Field Safety Corrective Actions (FSCAs) to prevent recurrence. Vigilance is mandatory for all supply chain actors: manufacturers, authorized representatives, importers, and distributors.
What Events Must Be Reported?
According to Article 87 MDR and Article 82 IVDR, the following must be reported:
- Serious incidents – events that led or could have led to death, serious deterioration of health, or life-threatening conditions, including incorrect IVD results.
- Field Safety Corrective Actions (FSCA) – technical or organizational measures implemented post-market to reduce risk to users or patients.
Reports are submitted to the competent authority in the relevant Member State and, per Article 92 MDR, to the EUDAMED system.
Role of PRRC in Vigilance
The Person Responsible for Regulatory Compliance (PRRC), as required under Article 15 MDR/IVDR, oversees the accuracy and completeness of incident and FSCA reporting, ensures alignment with technical documentation and risk analysis, and integrates vigilance into the quality management system. The PRRC is also responsible for timely communication with authorities and the notified body.
Incident Reporting Deadlines and Data Structure
Deadlines under MDCG 2023-3:
- Initial report within 2 working days – for serious public health threats
- Standard incident report within 10 working days
- Final report – after internal investigation concludes
Each report must include: SRN, device data (UDI-DI, type, serial number), incident description, contact information, root cause analysis, and FSCA plan.
Manufacturer Responsibilities Under Vigilance
Manufacturers must fully implement the Vigilance system, including:
- incident and FSCA analysis and reporting procedures,
- serious incident and user complaint log,
- Corrective and Preventive Action (CAPA) plans,
- effectiveness monitoring of corrective actions,
- integration with ISO 13485 and ISO 14971.
Integration of Vigilance With PMS, PMCF, and PSUR
Vigilance data should be analyzed within:
- PMS plan – per Annex III MDR/IVDR,
- PMCF (for MD) or PMPF (for IVD),
- Periodic Safety Update Report (PSUR) – for class IIa, IIb, III devices and class C/D IVDs.
Lack of integration leads to audit-detected inconsistencies.
Vigilance Obligations of Authorized Representatives, Importers, and Distributors
- Authorized Representative – cooperates with authorities, retains reports for 10 years, and forwards info to the manufacturer.
- Importer – immediately notifies the manufacturer of incidents and retains related documentation.
- Distributor – informs the manufacturer of customer complaints and suspected non-compliances.
Failure to respond or relay such information may result in administrative fines of up to PLN 5,000,000 as per the Medical Devices Act.
Vigilance and EUDAMED – New Obligations from 2026
Under Regulation 2025/1021:
- Incident and FSCA reporting will be mandatory via EUDAMED,
- XML format and SRN integration will be required,
- Reports must be standardized and suitable for public disclosure.
Lack of readiness may prevent compliance with Articles 92 MDR and 82 IVDR.
Mandatory Documentation for Vigilance
Recommended documentation set:
- Incident and FSCA reporting procedures,
- Forms aligned with MDCG 2023-3,
- FSCA and CAPA registry,
- Communication logs with authorities and notified bodies,
- Integration with PMS, PMCF/PMPF, and PSUR.
Common Deficiencies and Their Consequences
- Outdated incident reporting procedures,
- Missed 2/10-day deadlines,
- Ineffective CAPA actions,
- Lack of integration with PMS and PMCF,
- Failure to analyze user reports.
Such deficiencies are classified as major non-conformities during MDR/IVDR audits.
How Pure Clinical Supports Manufacturers with Vigilance
Pure Clinical supports medical device and IVD manufacturers with vigilance processes, including incident assessment, documentation, and reporting obligations related to incidents and field safety corrective actions under applicable MDR and IVDR requirements.
Services may include:
- Development and review of vigilance procedures and reporting forms, taking into account applicable requirements and MDCG guidance,
- Training for Regulatory Affairs (RA) and Quality Assurance (QA) teams on incident assessment, reporting, and corrective actions,
- Integration of vigilance processes with the quality management system, risk management, and CAPA processes,
- Support with documentation related to PSUR, PMCF, FSCA, and reporting to competent authorities and relevant electronic systems, including EUDAMED where applicable,
- Preparation of vigilance documentation and processes for Notified Body reviews and audits, and inspections by competent authorities, including the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), depending on the scope of the inspection.
The scope of support is adapted to the device type, the manufacturer’s obligations, and the applicable regulatory requirements.
FAQ
Is every CAPA action considered a Field Safety Corrective Action (FSCA)?
Will EUDAMED incident reports be publicly visible?
Who determines whether an incident requires an FSCA submission?