PMS / vigilance
Mastering Vigilance Reporting in Germany
Whitepaper · EU MDR 2017/745
PMS / vigilanceAllemagne / G-BAUSA / FDA
WHAT THIS PAGE COVERS
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Mastering Vigilance Reporting in Germany
European CRO for medical devices, aligned with Regulation (EU) 2017/745.
Trusted by manufacturers
Leading medical device teams work with Eclevar
A guide to post-market vigilance requirements for MedTech professionals.
Serious incidentsFSCABfArMGermany
In this whitepaper you’ll find
Stay compliant and keep patients safe across the device lifecycle. Complete the form to download the guide.
- ›The vigilance reporting obligations for medical devices on the German market under EU MDR
- ›How to identify and report serious incidents and Field Safety Corrective Actions (FSCA), with timelines
- ›The role of the BfArM and the manufacturer’s responsibilities post-market
- ›Understand your vigilance obligations for devices placed on the German market
- ›Report serious incidents and FSCA correctly and within the required timelines
- ›Build a robust post-market vigilance process aligned with EU MDR and international standards
EUCROF Platinum Award 2026xShare Open Call for Clinical Research, co-funded by the European Union
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Whitepaper · BSI × Eclevar
A BSI and Eclevar whitepaper on the EU MDR.
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, the same evidence your file has to support.
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