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