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MDCG and AIB release guidance on interplay between EU MDR/IVDR and AI Act
MDCG 2025-6 and AIB 2025-1, released on June 19, 2025, and setting out...
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European Commission releases updated MDCG 2019-11 guidance on software qualification and classification under MDR and IVDR
EU updates MDCG 2019-11 guidance on qualification and classification of medical device software
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MDCG 2025-04: New EU guidance on ensuring safe distribution of medical device software via online platforms
On June 16, 2025, the European Commission published the guideline MDCG 2025-4 outlining...
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Team NB Publishes Press Release on Certificates with Conditions
On 12 March 2025, the TEAM NB issued a press release on certificates...
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ISO 15223-1 First Amendment Published
The harmonized standard ISO 15223-1 defines the symbols used by medical device manufacturers...
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