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BVMed demands urgent clarification of SUDs (single-use medical devices) rules

This article was originally published in Clinica

Executive Summary

Under Germany's medical products law amendment (MPG), hospitals must give guarantees that reconditioned single-use medical devices are of equally high quality and performance as newly manufactured devices. This is the tone of a letter from the German industry association (BVMed) to the health committee of the Lower House of parliament (Bundestag). According to BVMed director Joachim Schmitt, the draft of the second MPG amendment law of June 1 does not require either hospitals or firms which recondition devices to comply with the guidelines for manufacturers laid down in the original MPG. This means that they are not subject to controls by auditors or certifying bodies.

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