A Guide of Clinical Investigation with Medical Devices in Europe: Pre- and Post-market requirements

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 as per MDR 2017/745 Articles 62 and 74.2

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.