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Incident notifications in Germany: correction:

This article was originally published in Clinica

Executive Summary

There is a mandatory requirement in Germany for manufacturers to notify the local competent authority about adverse incidents that occurred during clinical trials of medical devices and diagnostics. But all other reports concerning adverse incidents with CE-marked devices must be reported to the central authority and not the local authorities as reported in Clinica No 1045, p 5. They must be notified directly to the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute for certain IVDs, in line with community law. The local authorities are responsible for receiving other notifications, concerning manufacturing/or putting devices onto the market and notifications of clinical trials. Furthermore, the German law can only demand that companies based in Germany appoint a safety officer; this requirement does not apply to companies based outside the country.

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