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Factsheet for Manufacturers of Medical Devices

This Factsheet is aimed at manufacturers of medical devices.
For a general overview of the impact of the In-VitroMedical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in-vitro diagnostic medical devices. References to Annexes and Articles in this factsheet refer to the MDR (2017/745/EU).

 

Factsheet for manufacturers of medical devices

News & Trends

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Recentes

  • Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples
  • FARMACOVIGILÂNCIA nível avançado : Formação completa con casos práticos
  • FDA DRAFT GUIDANCE :Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
  • European Biotech Act: Positioning EU as Biotech Powerhouse
  • CIOMS Glossary of ICH Terms and Definitions. Version 10
  • Guidance on standardisation for medical devices Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1
  • MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
  • Commission Implementing Decision amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer

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