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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

  • EMA Article 57 Q&A Version 1.15 (9 September 2026)
  • EMA guidance on Electronic product information (ePI) submission during centralised procedures
  • EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Device Regulation (2017/746) – Impact on international registrations. Middle East and Africa focus
  • IMDRF Document Implementation Report. 1 September 2026
  • EU Regulatory News : IVD Classification Rules – MDCG 2020-16 Rev.5
  • Revised version of EU GMP Annex 19: Reference and Retention Samples
  • Evaluation of Therapeutic Equivalence. Guidance for Industry
  • FDA Considerations for the Regulation of Generative Al-Enabled Medical Devices: Discussion Paper and Request for Feedback

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