What is the IVDR?
The IVDR replaced the IVDD and entered into force on 26 May 2017. By 26 May 2022 all new IVDs placed on the market and Class A non-sterile had to comply with the IVDR. All IVDD CE certified devices must comply to the IVDR by 26 May 2025 or upon certificate expiry. Depending on the risk class, the transition period for IVDD self-declared devices is the 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. IVDD certified devices can no longer be placed on the market or put into service.
For self-certified IVDs already placed on the market under the IVDD, a sell-off period of one year is granted after Class D, C, B and A sterile compliance deadlines.