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  • Regulation - EU - 2024 1860 - EN - EUR-Lex
    Regulation (EU) 2024 1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017 745 and (EU) 2017 746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text
  • Regulation (EU) 2024 1860- the latest changes to MDR and IVDR
    Regulation (EU) 2024 1860 introduces significant changes to previous regulations on medical devices and in vitro diagnostic medical devices, with the aim of ensuring patient safety, a high level of public health protection and avoiding potential market disruption
  • EXTENSION OF THE IVDR TRANSITIONAL PERIODS - Public Health
    Regulation (EU) 2024 1860 also imposes a requirement on manufacturers to inform the relevant competent authority and health institutions before the supply of certain medical devices or IVDs is interrupted or discontinued
  • Regulation (EU) 2024 1860 of the European Parliament and of the Council . . .
    Regulation (EU) 2024 1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017 745 and (EU) 2017 746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text
  • EU Regulation 2024 1860 on Eudamed: New Obligations - Compliance Risks
    As per Regulation (EU) 2024 1860, Regulation (EU) 2017 745 and (EU) 2017 746 are amended to incorporate the new manufacturer obligation to report any potential interruption or discontinuation of supply of certain devices
  • Regulation (EU) 2024 1860 amending Regulations (EU) 2017 745 and (EU . . .
    Regulation (EU) 2024 1860 - adopted by the co-legislators on 13 June 2024 - introducing amendments to Regulation (EU) 2017 745 and Regulation (EU) 2017 746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical
  • Regulation (EU) 2024 1860: Extension of the IVDR transitional period . . .
    The Regulation (EU) 2024 1860 amending Regulations (EU) 2017 745 (MDR) and (EU) 2017 746 (IVDR) has been published in the Official Journal of the European Union (OJEU) The aim of this legislation is to ensure continuity of supply on the European market for in vitro diagnostic devices
  • New Regulation (EU) 2024 1860 amending the Regulation (EU) 2017 745 and . . .
    According to Amendment (EU) 204 1860, manufacturers and economic operators are obliged to inform about interruption or discontinuation in supply chain 6 month before the expected interruption or discontinuation, and specify the reason
  • EU Regulation 2024 1860: Key Changes for IVDR Compliance - MedEnvoy
    New regulation amending Regulations (EU) 2017 745 (MDR) and (EU) 2017 746 (IVDR): Regulation (EU) 2024 1860: Gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in-vitro diagnostic medical devices
  • Understanding the new Regulation (EU) 2024 1860 - Advena Ltd
    Understand the key requirements of Regulation (EU) 2024 1860 for medical device manufacturers, including compliance timelines and transitional provisions





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