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Ongoing guidance development within MDCG Subgroups

NEWS FROM EU:

Ongoing guidance development within MDCG Subgroups – October 2020*.
A lot of guidances planned in 2021!!!

 

Ongoing guidance development within MDCG Subgroups

 

 

 

 

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Recentes

  • 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
  • Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
  • Total Product Lifecycle Considerations for Generative AIEnabled Devices
  • MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)
  • Team-NB High level position on the regulatory framework for the medical devices sector
  • CONTROLO DE ALTERAÇÕES : Sessão esclarecedora com uma discussão bastante interessante sobre o assunto
  • EU Prosperity and Competitiveness: Recommendations for implementing the EU Green Deal in Healthcare
  • Consultation on ICH E6 (R3) Guideline for Good Clinical Practice Annex-2

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