Mudança Importante no Símbolo do Representante Autorizado Europeu (EC REP → EU REP): Fabricantes Devem Atualizar a Documentação
Há uma atualização de símbolo que você não pode ignorar.
Com o lançamento da Emenda 1 da ISO 15223-1, o símbolo do Representante Autorizado Europeu está mudando de EC REP para EU REP.
New MDCG 2024-8 Rev. 1 Document: Key Updates for Conformity Assessment under the IVDR
MDCG 2024-8 Revision 1 brings crucial updates for IVDR compliance, including streamlined processes for conformity assessment and updated guidelines for notified bodies. Stay informed about regulatory changes in in vitro diagnostic devices under Regulation (EU) 2017/746. Learn how Smart MDR can support your business with expert guidance on IVDR conformity, ensuring compliance with EU medical device regulations. From quality management systems to technical documentation, we help you navigate the complexities of regulatory frameworks with confidence.