HTA Procedure for High Risk Class Medical Devices (§ 137 h SGB V)

Executive Summary

The new HTA procedure for high-risk class medical devices can be summarised as follows (§ 137 h SGB V):

• Transfer of all documents by hospital and manufacturer to G-BA, the documents are then transferred to IQWiG
• Scientific evaluation of the potential and the benefit of the medical device. The process is completed with the preparation of the assessment according to §137 h SGB V
• Optional: Within the consultations on a testing directive, the G-BA can commission IQWiG to conduct a systematic literature search to ensure that all relevant studies are considered. This search is conducted in the form of an addendum