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  • How to Get Legacy Devices to IVDR Compliance | SGS USA
    This white paper provides a detailed roadmap for manufacturers looking to transition their legacy IVDs from IVDD to IVDR compliance It covers key areas such as: Understanding the transitional provisions – learn about the latest extensions and deadlines under Regulation (EU) 2024 1860
  • Regulatory requirements and challenges for new and old Class . . .
    On 9 July 2024, a new amendment (EU) 2024 1860 to the MDR and IVDR was published, introducing, among other things, new extended transitional provisions for certain IVDs (legacy devices) This is the third amendment with extended transition timelines since 2017 (date when IVDR was published)
  • MDCG 2022-8: Clarification of IVDR Requirements for Legacy . . .
    Why would the authors of the MDCG 2022-8 deliberately separate out “old devices” versus “legacy devices?” Regulators are imposing many more IVDR requirements for “legacy devices” compared to the “old devices,” so there are notable differences
  • Which IVDR items apply to IVDD Legacy Devices . . . - Casus . . .
    MDCG 2022-8: Regulation (EU) 2017 746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98 79 EC It provides guidance on which aspects of the IVDR apply to ‘legacy’ and ‘old’ devices Why is this important?
  • IVDR Compliance for Legacy Devices (Step-by-Step Guide . . .
    Legacy IVD devices—those already placed on the market under the IVDD—must now meet stricter requirements under the IVDR (EU 2017 746) to maintain market access If you’re a manufacturer of legacy devices, this blog will help you understand how to achieve IVDR compliance within the transitional timelines
  • IVDR 2025 Deadline: Key Requirements for Legacy IVDs Under EU . . .
    Legacy in-vitro diagnostic devices must comply with IVDR by 26 May 2026 Learn key deadlines, QMS requirements, and how Obelis can support your transition





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