In Vitro Diagnostic Medical Devices Manufacturer, according to risk classes, have the following transition periods available for the application of IVDR (EU) 2017/746 Regulation:

  • Until 26th May 2022 for class A non-sterile IVD Devices and for in Vitro Diagnostic Medical Devices CE-marked which do not require the involvement of a Notified Body
  • Until 26th May 2025 for higher risk devices (class D)
  • Until 26th May 2026 for class C devices
  • Until 26th May 2027 for class B devices and class A sterile devices.

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