MDR / reglementaire
SAE Reporting in Germany
Whitepaper · EU MDR 2017/745
MDR / reglementaireISO 14155 / investigation cliniqueAllemagne / G-BAUSA / FDA
WHAT THIS PAGE COVERS
1
SAE 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 for clinical investigations under MDR 2017/745.
Articles 62 & 74.2Sponsor & investigatorEthics CommitteeGermany
In this whitepaper you’ll find
Don’t miss this essential resource for ensuring the safety of medical devices during clinical studies. Complete the form to download it now.
- ›The requirements for reporting Serious Adverse Events (SAE) in clinical investigations under Articles 62 and 74.2 of the MDR in Germany
- ›Investigator and sponsor responsibilities, including the timelines for event reporting
- ›The clear distinction between reportable events during clinical investigations and vigilance reporting
- ›Understand the specific requirements for SAE reporting in clinical investigations in Germany
- ›Plan your clinical studies with regulatory and Ethics Committee requirements in mind
- ›Optimize the process for tracking and reporting SAEs, in line with 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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