IVDR progressive roll-out has been officially published!

The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for IVDs requiring the involvement of a Notified Body under the IVDR! We have previously reported on MDlaw each step of the process starting with the European Commission’s proposal and the European Parliament and the Council’s adoption.

While the IVDR date of application remains unchanged, the transitional periods will vary depending on the class of a device:

• 26 May 2025 for class D devices & devices with a valid IVDD Certificate [can be made available/put into service until 26 May 2026: this sell-off provision was deleted by Regulation (EU) 2023/607 on March 20, 2023]
• 26 May 2026 for class C devices [can be made available/put into service until  26 May 2027: this sell-off provision was deleted by Regulation (EU) 2023/607 on March 20, 2023]
•  26 May 2027 for class B devices [can be made available/put into service until 26 May 2028: this sell-off provision was deleted by Regulation (EU) 2023/607 on March 20, 2023]
• 26 May 2027 for class A devices placed on the market in sterile condition [can be made available/put into service until 26 May 2028: this sell-off provision was deleted by Regulation (EU) 2023/607 on March 20, 2023]

Thus, up-classified devices and devices with an IVDD CE Certificate (considered legacy) will need to continue complying with certain aspects of IVDR as of the date of application of the regulation – 26 May 2022 –  if no significant change to design or intended purpose has been made. Please bear in mind that full compliance with the IVDR should be achieved at the latest by the above dates highlighted in bold.

Moreover, the European Commission has also extended this proposal to In Vitro Diagnostic Devices that are manufactured and used within the same health institution (the so-called “in-house devices“) with date of application of the IVDR being moved to 26 May 2024 and 26 May 2028.

Please kindly note that this proposal does not affect IVDs that do not require a Notified Body involvement under IVDR or “new” IVDs. For these devices the date of application would still be 26 May 2022.

Find the full text of the new Regulation in our Library – LAW!