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EU: New guidance on medical device standards development

  • Writer: ARQon
    ARQon
  • Jul 8, 2021
  • 1 min read

The European Commission’s Medical Device Coordinating Group (MDCG) has issued new guidance explaining the role of safety and performance standards under current Medical Device Directives as well as the upcoming Medical Devices Regulation (MDR) and In-vitro Medical Devices Directive (IVDR).


In the new guidance, the essential safety requirement has been heightened which includes clinical evidence, key cybersecurity requirement and all the amount of pre- and post-market evidence needed to demonstrate medical device safety and performance have significantly increased.

See also: Journal of Medical Device Regulation, MDR guide (https://www.mdr.guide/ivdr)

 
 
 

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