The German Central Federal Agency for Health Protection (ZLG) releases a document concerning evaluation of clinical data by the notified bodies.
This document is also based on MEDDEV 2.7.1-„Goldstandard“. This means that the notified bodies are challenged by the ZLG to evaluate clinical data according to MEDDEV 2.7.1.
In particular it refers to the comparability of clinical data.
The German Central Federal Agency for Health Protection in Pharmaceuticals and Medical Products
The ZLG represents the coordination body of the federal states in the field of human and veterinary medicine. Its duties include pharmacovigilance in Germany covering the coordination of the individual activities of the federal states as well as the cooperation with the European Union. Moreover the ZLG is the national authority responsible for the certification of the notified bodies in the field of medical devices.