Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

The European Parliament, by publishing the EU 2022/112 Regulatory, modified the transitional periods, initially foreseen by IVDR art. 110, as following:

  • Certificates issued by Notified Bodies in conformity with IVDD directive before 25th May 2017 are still valid until the expiry date indicated on the certificate, except for certificates issued in accordance with directive Annex IV which lose validity on 27th May 2025
  • Certificates issued by Notified Bodies starting from 25th May 2017 lose validity on 27th May 2025

👉Such IVD Devices can be placed on the market or put into service until 26th May 2025.

  • IVD Devices for which the conformity assessment procedure under IVDD directive did not require the involvement of a Notified Body, with the declaration of conformity drawn up before 26th May 2022 and for which the conformity assessment procedure under the IVDR Regulation now requires the involvement of a Notified Body, can be placed on the market, or put into service until the following dates:
  • 26th May 2025 for class D IVD devices
  • 26th May 2026 for class C IVD devices
  • 26th May 2027 for class B and class A sterile IVD devices.
  • IVD Devices placed on the market after 26th May 2022 can still be placed on the market or put into service until the following dates:
  • 26th May 2026 for class D IVD devices
  • 26th May 2027 for class C IVD devices
  • 26th May 2028 for class B and class A sterile IVD devices.

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