Tag
IVDR
4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746
Wednesday, March 19th 2025
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4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746
The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)
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2nd call launched by the European Commission for applications for EURLs on high-risk IVDs
Tuesday, March 11th 2025
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2nd call launched by the European Commission for applications for EURLs on high-risk IVDs
In February 2025, the European Commission, after consultation with the Member States in the Medical Device Coordination Group (MDCG), launched (...)
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European Medicines Agency Q&A guidance on the implementation of the MDR and IVDR update
Thursday, February 13th 2025
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European Medicines Agency Q&A guidance on the implementation of the MDR and IVDR update
The EMA has updated its Q&A guidance on the implementation of EU regulations for medical devices and in vitro diagnostic medical (...)
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