Eclevar's Whitepaper Series
A Guide of Clinical Investigation with Medical Devices in Europe
This whitepaper summarizes the different types of clinical investigations in the EU as per MDR 2017/745, the submission routes and submission documents, and also on reporting requirements during conduct, and after completion of a clinical investigation.
Germany SAE Reporting for Clinical Investigations
This paper provides you with an overview of SAE reporting requirements for clinical investigations
with Medical Devices as per MDR 2017/745 Articles 62 and 74.2 in Germany, supporting you to
report in a timely and correct manner.
