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    Regulatory Services

    In Vitro Diagnostic Regulation (IVDR)

    The IVDR replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application.

    On March 2023, by means of (EU) 2023/607, IVDR Article 110(4) was amended with the removal of the sell-off period to prevent unnecessary disposal of safe IVDs still in the supply chain.

    On April 2024 (EU) 2024/xxx has been published in the OJEU extending transition timelines for certain IVDs.

    Only legacy devices may benefit from the extended transition period if:

    • The device continues to comply with IVDD requirements
    • There are no significant changes in design or intended purpose or the device
    • The device does not present an unacceptable risk to the health and safety of patient
    • The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025
    • The manufacturer has lodged a formal application with a NB by May 2025 for IVDD certified and class D self-declared IVDs, by May 2026 for Class C self-declared IVDs and by May 2027 for class B and A-Sterile IVD
    • The manufacturer has signed a written agreement with a NB by September 2025 for IVDD certified and class D self-declared IVDs, by September 2026 for Class C self-declared IVDs and by September 2027 for class B and A-Sterile IVDs

    If those requirements are fulfilled, the transition period is extended to:

    • 31 December 2027 for IVDD certified devices and Class D self-declared devices
    • 31 December 2028 for Class C self-declared devices
    • 31 December 2029 for Class B and A-Sterile self-declared devices
    (IVDR) (EU) 2017/746
    Resources

    Additional resources to support you

    Key changes of the IVDR

    The major areas of change in the IVDR include:

    • Rule-based classification system

    • Requirements for clinical evidence and post-market performance follow-up

    • Increased traceability of devices (UDI)

    European Union

    In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746

    BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under IVDR. We are also a full-scope UK Approved Body (0086) assessing medical IVDs against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your device to the market.

    For more information visit our CE marking and UKCA marking dedicated webpages.

    CE Marking UKCA Marking
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    Time for your IVDR application is now

    "If you do not have an agreement with a Notified Body reach out today and if your technical documentation is ready, there is really no reason to delay your IVDR application"

    Elizabeth (Liz) Harrison, Global head of IVD at BSI

    Apply now
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    Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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