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...
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...
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...
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...
Wien, 20.12.2023 – Text: Catarina Carrão The EU AI Act The Council presidency and the European Parliament have agreed on a provisional agreement on the proposal...
Wien, 06.11.2023 – Text: Catarina Carrão Pharmaceutical Legislation Revision: objectives In April 2023, the European Commission (EC) has adopted a proposal for a new Directive and a...
Wien, 01.10.2023 – Text: Catarina Carrão With the impact of the COVID-19 pandemic, Decentralized clinical trials (DCTs) and digital health technologies (DHTs) gained a momentum...
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