News Categories

In Vitro Diagnostic Regulation (IVDR)

2025-03-07

The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application

In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent unnecessary disposal of safe in vitro diagnostic medical devices that are still in the supply chain.

By 26 May 2022 all new IVDs placed on the market and Class A non-sterile devices had to comply with the IVDR.

(IVDR) (EU) 2017/746

11 / 23

All IVDD CE certified devices must comply with the IVDR by 26 May 2025 or upon certificate expiry

Depending on the risk class, the transition period for IVDD self-declared devices is 26 May 2025 for Class D devices and extends to 26 May 2026 for Class C devices and to 26 May 2027 for Class B and A sterile devices. On 27 May 2027 all devices must comply with IVDR.

The sell-off period for self-certified IVDs already placed on the market under the IVDD has been removed. These devices can be made further available on the market without legal time restrictions. For in-house devices, the requirement to justify that an equivalent device is not available on the market is postponed until May 2028.

Read latest IVDR news

Article reprinted in: https://www.bsigroup.com/en-US/products-and-services/medical-devices/ivdr/

As a company that values technological innovation and product quality, we are committed to providing our customers with products that are safe, reliable, and of superior performance. We firmly believe that this product will bring you convenience and enjoyment. We will make unremitting efforts and keep innovating to meet your needs. Please do not hesitate to contact us immediately. We look forward to providing you with more assistance and support. Thank you for your inquiry and cooperation.