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New German devices law relaxes original proposals on trial authorisations

This article was originally published in RAJ Devices

Executive Summary

The German lower house of parliament (Bundestag) has passed the amended Medical Devices Act, which will now become law1,2. In a last-minute change to the amended act, the Bundestag bowed to a request from the upper house (Bundesrat) to ease the rules on the authorisation of clinical trials3.

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