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 25^th 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 27^th May 2025
• Certificates issued by Notified Bodies starting from 25^th May 2017 lose validity on 27^th May 2025

👉Such IVD Devices can be placed on the market or put into service until 26^th 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 26^th 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:
• 26^th May 2025 for class D IVD devices
• 26^th May 2026 for class C IVD devices
• 26^th May 2027 for class B and class A sterile IVD devices.

• IVD Devices placed on the market after 26^th May 2022 can still be placed on the market or put into service until the following dates:
• 26^th May 2026 for class D IVD devices
• 26^th May 2027 for class C IVD devices
• 26^th May 2028 for class B and class A sterile IVD devices.

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