Better ensure the safety, effectiveness and health benefits of medical devices

Summary

Elimination of deficiencies in the existing approval and monitoring process for medical devices, market release and monitoring of implants, study register, benefit assessment, information on the electronic health card, amendment to SGB V, long-term monitoring of implants, regulations in the planned Patient Rights Act on implant identification, access to manufacturer information and patient information, proof of a Insurance provision by implant manufacturers, changes to the Medical Devices Act

Machine translation from German. The official text remains authoritative.

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2 official files

• 17/12088

  Drucksache · DE · 16 January 2013

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• 17/8920

  Drucksache · DE · 7 March 2012

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