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para profissionais da área Pharma , MedTech
e Suplementos Alimentares
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AI Act Complaints tool
The European Commission has introduced the AIActComplaintsTool, allowing individuals and organisations to submit a complaint to the AI Office when they believe that a provider or deployer of an AI system may have infringed the AI Act. The AI Act Complaints Tool...
EU MDR Update: New Harmonised Standards for Medical Devices
The European Commission has published Implementing Decision (EU) 2026/2479, introducing an important update to the harmonised standards supporting Regulation (EU) 2017/745 (MDR).
Clinical evidence for orphan in vitro diagnostic medical devices
This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The...
Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
The European Medicines Agency (EMA) has released Revision 24 of its nitrosamine Q&A, introducing several important updates: https://lnkd.in/gAvk967S
Comprometidos com a qualidade e a inovação.
