by administrador | Ago 2, 2024 | Medical Devices
EUDAMED: Regulamento 2024/1860 e novas datas O que é a EUDAMED? A EUDAMED é a base de dados europeia sobre dispositivos médicos, desenvolvida pela Comissão Europeia para centralizar e simplificar as informações relativas a dispositivos médicos, dispositivos de...
by administrador | Jul 5, 2024 | Medical Devices
Decreto-Lei n.º 29/2024 e a Conformidade de Dispositivos Médicos em Portugal: Conheça as Principais Alterações Novo Decreto-Lei n.º 29/2024 sobre Dispositivos Médicos Foi publicado no passado dia 5 de abril o Decreto-Lei n.º 29/2024, que assegura a execução nacional...
by Suporte | Fev 1, 2023 | Medical Devices
Breaking Down Notified Bodies’ Standard Fees: What You Need to Know The European Commission’s Medical Device Coordination Group (MDCG) has issued new guidance on the standard fees that Notified Bodies (NBs) must publish for conformity assessment and...
by Suporte | Fev 1, 2023 | Medical Devices
Extension of the EU MDR transition period – Recent Developments With EU Members arguing legislative measures had to be put forward to help prevent potential medical device shortages, the European Commissioner for Health and Safety proposed measures to extend the...
by Suporte | Fev 1, 2023 | Medical Devices
What you need to know – UDI in the MDR The new Medical Device Regulation 2017/745 (MDR) changed and introduced various requirements to obtain regulatory approval for medical devices in the EU. One of these is the introduction of the UDI – Unique Device Identifier, an...
