Regulatory & Compliance
Medical Device Vigilance.
We help medtech companies establish an MDR-compliant vigilance system: from incident assessment and regulatory reporting to the management of field safety corrective actions (FSCA).
What vigilance reporting requirements does the MDR impose on manufacturers?
The MDR (EU) 2017/745 has significantly tightened vigilance requirements for medical devices and increased the pressure on manufacturers:
- Serious incidents must be reported to the authorities extremely quickly—within 15, 10, or even 2 days, depending on the severity.
- Statistical trend reporting is now mandatory even for non-serious incidents.
- Field Safety Corrective Actions (FSCA) and recalls must be precisely coordinated, documented in multiple languages, and escalated.
- Notified bodies and authorities (such as the BfArM) conduct detailed reviews of the implemented vigilance system to identify any gaps.
Do you have processes in place to ensure that critical incidents can be assessed and reported worldwide within 48 hours?
Our vigilance services for the medical technology industry.
We help you transform your vigilance process from a reactive obligation into a secure, proactive management tool.
Establishment of a Vigilance System (MDR)
Development of the entire process: incident assessment, reporting channels, escalation rules, and communication. Documentation in the form of an audit-ready set of SOPs with clearly defined responsibilities (PRRC).
Assessment & Decision on Reporting
Operational support in the assessment of critical incidents: causality, severity, and reporting requirements. Review of decisions and preparation of MIRs (Manufacturer Incident Reports) that comply with regulations.
FSCA & Communication with Government Agencies
Coordination of field safety corrective actions (recalls, warnings). Liaison with regulatory authorities (BfArM, FDA) and preparation of field safety notices (FSN) for your customers.
Trend Reporting & Signal Detection
Establishment of a systematic trend-monitoring system for recurring, non-critical issues. Early detection of warning signs and seamless integration into the PMS cycle.
Frequently Asked Questions About Medical Device Vigilance.
What events must be reported under MDR?
Serious incidents (those resulting in death, serious injury, or near-misses), FSCAs, and significant statistical trends in non-serious incidents must be reported.
What are the strict reporting deadlines?
The deadline begins when the manufacturer is notified: 15 days for "normal" serious incidents, 10 days for serious threats to public health, and only 2 days in cases of imminent danger of death.
What is the difference between PMS and vigilance?
PMS (Post-Market Surveillance) refers to proactive, general market monitoring and data collection. Vigilance is the highly reactive component of this system: the rapid, legally mandated reporting of specific incidents.
Which government agencies must reports be submitted to?
Reports are submitted to the competent national authority in the country where the incident occurred (e.g., BfArM in Germany). In the future, this will be handled centrally across Europe via the EUDAMED database.
Additional expertise in the post-market sector.
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