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Regulatory IVDD

CE-Marking compliance:

CE-marking compliance for In Vitro Diagnostic Device (IVD) manufacturers entails mainly two major steps.

 

1) FILES: First the Design history file/ technical file of the device has to be state of the art and has to comply to the responsible annex of the directive.

 

2) QMS: Secondly the manufacturer has to have an effective working quality management system in order to guarantee a well controlled production. 

Both steps have to be accepted by a Notified Body before the approval and certification of the device can be received. Only after the CE-mark has been provided you are allowed to place your products on the CE markets.

 

FILES:

  • IVDD full scope compliances; from Annex II List B low to Design dossiers for self-testing devices (Annes III.6).

 

QMS Audits:

  • Regulatory compliance audit according IVDD Annex IV and Annex VII.
  • ISO 13485:2003; ISO 13485:2003 under CMDCAS necessary for Canadian regulatory complaince.