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EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS

Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

REV. 2. JULY 2024

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Recentes

  • EU MDR Update: New Harmonised Standards for Medical Devices
  • Clinical evidence for orphan in vitro diagnostic medical devices
  • Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
  • TEAM NB Code of Conduct for Notified Bodies vs 5.3
  • GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
  • New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
  • AI in pharmacovigilance – EMA update
  • Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”

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