2023 Mid-Year Regulatory Updates: EU, UK, and Switzerland
19 June 2023
MDCG Issues Addendum to Guidance Document MDCG 2022-18
30 June 2023The EU Commission announced its will soon release new Common Specifications for Class D IVD devices: HERE
It is for detecting the following in blood transfusion, tissue and organ transplantation, and cell administration:
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- hepatitis E
- toxoplasma gondii
- Plasmodium (malaria)
- four types of arboviruses (dengue, Chikungunya, West Nile and Zika viruses)
The draft act will soon be released, and Commission adoption is planned for Q4 2023.
Once the Commission Implementing Regulation is adopted, Casus will update its: List of EU MDR/IVDR Harmonized Standards & Common Specifications
