Evnia 𝐍𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 𝐀𝐥𝐞𝐫𝐭! March’s edition is here with a bigger-than-ever Deep Dive section!
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This month
- We discuss the key takeaways for the EU Commission’s High-Level Conference on Medical Devices in Brussels
- We help you understand better FDA’s alternatives to Animal Testing in Drug Development
- We get you ready for the after-MAUDE era as the FDA’s database becomes obsolete in May 2026
- We interpret the European Commission’s expanded list of Well-Established Technologies under MDR
- We take a first dive in the updated ISΟ 14155:2026 and explain how it will change the clinical investigations in Europe
- We summarise the impact for MedTech/Biotech & Pharma of the EU Parliament’s adoption of the Digital Omnibus on AI
- If you are working in pharma or biotech, go through our detailed overview of the EU Pharma Package to navigate through the new requirements and how they will shape access to medicines for European patients
