January Newsletter: MDR CE Marking
Published on 28 October 2025,
Following the filing of the Physiological Serum in single-dose form with our French Notified Body
DIS.PAR and its Quality and Regulatory Affairs teams are pleased to inform you of the award of the
According to Regulation (EU) 2017/745 on medical devices or ” Medical Device Regulation” (MDR), a new regulation that emerged in the wake of the PIP health scandal tightening rules on Medical Devices.
After submitting our application in 2022, weeks of auditing, and several rounds of evaluation, we are very proud to be among the first to obtain it! We have made substantial financial and human investments to meet the most stringent quality and safety requirements.
DIS.PAR has obtained MDR CE Marking, taking over from LDPSA certification obtained under Directive 93/42 regulations. Our teams will keep you informed of the labeling changes to be finalized by the end of 2026 at the latest. Other CE marking applications have been submitted.
More to come!
