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German Medical Devices Act

This article was originally published in The Gray Sheet

Executive Summary

Second amendment expanding surveillance of device reprocessing will go into effect in January, following passage by the German parliament. The law requires standard conformity assessment of reprocessed devices if the products are not returned by the third party to the original user. Additionally, external reprocessors will be incorporated into CA surveillance systems and be obligated to register any reprocessed devices. Advertising regulations will be modified under the amendment, which also addresses Internet advertising and the creation of a patient-oriented information policy...
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