The corrigendum to the IVDR includes minor editorial changes and alterations related to the delay of EUDAMED.
A potentially more impactful correction is situated in Annex VIII, Rule 2. The introductory phrase has been updated from:

  • Old: “Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, …” to 
  • New: “Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood, …”

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us

 

QARAD B.V.B.A.

ISO 13485 Certified

Follow us on:

Quicklinks

Website by Contents by Qarad Terms and conditions  Privacy policy  Cookie policy 
Close

Attention!

This website uses cookies to enhance your surfing experience.
Certain webfunctions rely on the usage of these cookies.
If you want more information regarding our cookie policy, you may visit this link.