2nd IVDR Corrigendum

Tuesday, December 3rd, 2019, the European Parliament’s Committee on the Environment, Public Health and Food Safety voted to adopt a second corrigendum to the IVD Regulation 2017/746. This second round of corrigenda (MDR and IVDR) still have to be approved by Parliament.

Read also our news article regarding the corrigendum to the MDR 2017/745

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.

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October 11-13

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