• Inicio
  • Formações
  • Formação à Medida
  • News & Trends
  • Sobre nós
  • Contacto

EMA Updates Q&A on MDR, IVDR

The European Medicines Agency (EMA) on Tuesday released an updated and revised questions and answers (Q&A) document on the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations

download here:

Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (With Track Changes)

News & Trends

Procurar

Recentes

  • Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
  • MDCG Position Paper: UDI assignment between manufacturers and distributors
  • EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
  • EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
  • MHRA Updated guidance for the International Recognition Procedure (IRP)
  • MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
  • Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
  • FDA Guidance for Drug Development

91 257 00 03 (Chamada para a rede móvel nacional)
info@formiventos.com

  • Follow
  • CLIENTES & TESTIMONIALS
  • ASSOCIAÇÕES OFICIAIS
  • CERTIFICAÇÕES E CREDITAÇÕES
  • ADVISORY BOARD
  • Política de Privacidade
  • Contacto