EUDAMED user guide UDI Devices Release 3.022

Recentes

• BOAS PRÁTICAS de FARMACOVIGILÂNCIA : ” Formação completa, contempla os pontos principais de Boas Práticas de Farmacovigilância “
• New EMA GMP Guidelines in the next three Years : The 3-year work plan for the Inspectors Working Group
• Formação QUALITY MANAGEMENT SYSTEM: ” Ótima forma de rever temas e aprofundar conhecimentos com casos do dia -a-dia “
• C(2026) 1809 expands the list of Class IIb implantable devices exempt from the obligation to perform an assessment of technical documentation for every device under Article 52(4).
• EU PARLIAMENT Textes Adopted on AI – 26/03/2026 Simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
• Registo Investigação e Tratamento de RECLAMAÇÕES : “Muito útil para melhorar os processos já implementados “
• ISO 20417:2026 – Updated Guidance on Medical Device Information – The second edition of ISO 20417:2026 (Medical devices – Information to be supplied by the manufacturer) has just been published.
• COMMISSION DELEGATED REGULATION (EU) …/… amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the list of implantable devices and class III devices exempted from the obligation to perform clinical investigations C/2026/1798 final