The IVDR has applied since May 26, 2022. It introduced a risk-based classification into classes A to D, with notified body involvement for most devices above class A, which meant far more diagnostic devices needed certification than before. Regulation (EU) 2024/1860 extended the transition periods for legacy devices to between 2027 and 2029, depending on class. The December 2025 revision proposal covers the IVDR as well, and has not been adopted.
Why it matters for labeling
IVDs have their own labeling requirements in Annex I, Chapter III, including the intended purpose, storage and stability information, symbols from ISO 15223-1 and the UDI. Many IVD kits have several components, each with its own label, plus a multilingual IFU, so keeping every variant aligned with the approved master is a particular challenge.
Common mistakes
- Kit component labels that don't match the outer carton or the IFU
- Storage and stability statements out of step across language versions
- UDI data that differs between packaging levels
- Assuming MDR labeling rules apply unchanged to IVDs