Promepla obtains CE marking | EU certificate (MDR)
Promepla S.A.M. has received its CE marking certificate for almost 90 of its products under Regulation (EU) 2017/745 on medical devices (MDR).
The certificate, issued by the Italian notified body IMQ S.p.A (0051), covers class Is (sterile) and class IIa devices, divided into 5 families:
ophthalmology
dental
infusion
general surgery
general surgery smoke evacuation.
This CE mark confirms Promepla’s position as a leading player in the field of medical devices.
As a reminder, medical devices (MD) cannot be released in Europe without CE marking.
All MD manufacturers must implement a quality management system within their organisation. In July 2024, Promepla S.A.M. renewed its ISO 13485 certificate, a guarantee of compliance and continuous improvement. In order to affix the CE mark, an MD manufacturer must also compile technical documentation (TD) that meets the requirements of European regulations (MDR) and demonstrates the safety and performance of its products.
