Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices
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Recentes
- 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”