Guerbet Complies with New EU Medical Device Regulation
French pharmaceutical company Guerbet has announced its compliance with the new European Medical Device Regulation (MDR), which became applicable on May 26, 2021.
Guerbet, a pharmaceutical company based in France, has stated its adherence to the European Medical Device Regulation (MDR). The regulation (EU) 2017/745 came into force on May 25, 2021, replacing the previous Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.
Guerbet initiated a strategic project several months ago to ensure compliance with the MDR. The company has confirmed that its manufactured, imported, and distributed medical devices meet the requirements of this new regulation, which took effect on May 26, 2021.
While some of Guerbet's product ranges have already transitioned to EU MDR CE marking, the regulation allows a grace period where existing MDD certificates remain valid. Guerbet is working with its EU Notified Bodies, which are already MDR-notified, to ensure the remaining product ranges are transitioned to MDR CE marking before their current MDD certificates expire.
The company will provide further notification once the transition is fully completed and the respective MDR EC certificates are issued. Brigitte d’Hautefeuille, Acting VP of Quality Technical Operations, and Julien Valla, EU MDR Strategic Project Manager, have overseen this initiative.