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EU CTR: Transparency

Wien, 15.04.2024 – Text: Catarina Carrão In the end of January 2022, the EU CTR (EU/536/2014) came into effect within the European Union (EU), replacing...

EU MDR and The Need For Clinical Evidence

Wien, 12.03.2024 – Text: Catarina Carrão Since the establishment of the EU Medical Devices Regulation (MDR EU 2017/745), Notified Bodies (NBs) have their hands full...

From EMA for Pharma SMEs: Updated User Guide

Wien, 15.02.2024 – Text: Catarina Carrão On the 23rd of January 2024, the European Medicines Agency (EMA) released a major revision of its user guide for micro, small...

EUDAMED Gestalt

Wien, 17.01.2024 – Text: Catarina Carrão EUDAMED: basics The European database on medical devices (EUDAMED) is an information technologysystem being built and implemented by the European Commission...

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