National emergency plan to ensure patient care - patient treatment is not jeopardized by the EU Medical Device Regulation

Summary

Suspension of the new European Medical Device Regulation (MDR) until all necessary European regulations have been submitted. Legal acts and until all notification bodies are fully operational, a transitional period of five years for the placing on the market of existing products and in this regard. Reduction or suspension of the new documentation requirements, recognition of the MDR approval regulations by the Federal Joint Committee (G-BA), creation a shortened examination procedure ("short track"), full functionality of the EUDAMED database when the MDR comes into force

Machine translation from German. The official text remains authoritative.

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2 official files

• 19/17589

  Drucksache · DE · 4 March 2020

  ViewDownloadOpen at official source

• 19/15070

  Drucksache · DE · 13 November 2019

  ViewDownloadOpen at official source

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