Evnia 𝐍𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 𝐀𝐥𝐞𝐫𝐭!
April’s edition is here with several updates and deep-dive articles!
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This month
📌We discuss the key takeaways of the latest MDCG 2021-24 about the classification of medical devices
📌We help you understand better the new additions in the manual on borderline and classification of medical devices under MDR
📌We summarise the impact of the FDA’s rejection of the Harrison.ai petition for partial exemption from the premarket notification requirements
📌We report on the adoption of the Digital Omnibus on artificial intelligence by the European Parliament
📌If you are working with PSURs, take a closer look at the comparison of EU vs UK requirements
