The European Commission has initiated a consultation period to consider amendments to Regulation (EU) 2022/1107, which was originally adopted in July 2022. This regulation specifically addresses IVDs designed for the detection and quantification of a range of serious infectious agents and bloodborne pathogens.
These include:
-
- HIV
- Human T-cell lymphotropic virus
- Hepatitis B, C, D, vCJD, CMV, EBV
- Treponema pallidum
- Trypanosoma cruzi
- SARS-CoV-2
As well as determining:
-
- ABO
- Rhesu
- Kell
- Kidd
- Duffy blood groups
The deadline for feedback is 16th September 2024.
Common Specifications are adopted where no harmonized standards exist or are sufficient, and if there is a need to address public health concerns. In this draft amendment, there is an update to annexes II to XX.
Feedback can be submitted through here.
Links to full document can be found here.
Draft amendment to class D IVD common specifications can be found here.
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If you have any questions about Regulation (EU) 2022/1107 or need regulatory help in bringing your medical device to the EU market, contact us so we can help you.
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