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Germany Preparing Vigilance Guidance, EC Directives Transposition Law

This article was originally published in The Gray Sheet

Executive Summary

The German Federal Ministry of Health's plan to introduce this year a comprehensive "safety plan" for regulating the medical devices vigilance system will complement a European Commission guidance document on medical device surveillance.

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SUD Reprocessing Guideline Lends Weight To German User Requirements

The German Federal Ministry of Health plans to issue a device reprocessing guideline this summer to herald an amendment to the Medical Devices Act requiring registration from third-party reprocessors.

SUD Reprocessing Guideline Lends Weight To German User Requirements

The German Federal Ministry of Health plans to issue a device reprocessing guideline this summer to herald an amendment to the Medical Devices Act requiring registration from third-party reprocessors.

German reuse

Reprocessing of single-use medical devices without validation of cleaning, disinfecting and sterilization processes "in such a way that the success of these processes is guaranteed in a reconstructable manner" is prohibited in the German Operation Ordinance for Medical Devices, according to a Dec. 21 release from the Federal Association of the Medical Device Industry in Germany (BVMed). Hans-Georg Will, department head at the German Federal Institute for Drugs and Medical Devices, notes at a recent conference that without such documentation "the reprocessing of medical single-use devices is not admissible legally"

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