The document contains a comprehensive set of amendments aimed at simplifying the EU AI Act’s implementation, improving proportionality for SMEs/SMCs, reinforcing AI Office powers, prohibiting harmful AI misuse (like sexual deepfakes), clarifying conformity assessments, enabling real‑world testing, and aligning AI rules with sector‑specific safety legislation.
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- EU MDR Update: New Harmonised Standards for Medical Devices
- Clinical evidence for orphan in vitro diagnostic medical devices
- Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
- TEAM NB Code of Conduct for Notified Bodies vs 5.3
- GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
- New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
- AI in pharmacovigilance – EMA update
- Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”