Using Own Device as Equivalent Device During MDD to MDR Transition

They can stay Class I under MDD until 2024. After that, you’ll need to comply with MDR and potentially be reclassified depending on the intended use and risk according to the new rules.

If you haven’t introduced significant changes to the device, and the data collected under MDD is sufficient, you generally wouldn’t need an equivalent device—the device itself serves as its own reference. However, if there are changes (like updates to the algorithm or UI), you should update your Clinical Evaluation Report (CER) to address these differences and demonstrate that prior data is still applicable. MDCG guidance allows use of your own device's pre-clinical data as long as you can justify equivalence and the data matches the current version’s intended purpose and performance.