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
- EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements
- ICH E20 draft guideline on adaptive designs in confirmatory clinical trials
- Critical shortages of medicines. European Court of Auditors’ Special Report
- EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
- Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR). MEDTECH E-BOOK
- A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Version 4 – September 2025
- ICH adopts M14 guideline on observational studies