Use EU trilogue negotiations for more patient safety in medical devices

Summary

Demands to tighten the approval and control of implantable high-risk medical devices in the preparation of the EU trilogue negotiations on the Medical Devices Regulation and the In Vitro Diagnostics Regulation, proof of effectiveness, approval and conduct of clinical trials, Declaration of Helsinki, expansion of the supplementary assessment of the expert commission, increase in transparency and the requirements for personnel of certification bodies (“Special Notified Bodies”), product liability insurance for manufacturers

Machine translation from German. The official text remains authoritative.

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  Drucksache · DE · 11 November 2015

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