Promepla S.A.M. has received its CE marking certificate for almost 90 of its products underRegulation (EU) 2017/745 on medical devices (MDR). The certificate, issued by the Italiannotified body IMQ S.p.A (0051), covers class Is (sterile) and class lla devices, divided into 5families: ophthalmology, dental, infusion, general surgery and general surgery smokeevacuation. Promepla S.A.M. also markets MDR self-certified class I medical devices.
This CE mark confirms Promepla’s position as a leading player in the field of medical devices.
Michel Sasportes, CEO of Promepla, comments: ‘Obtaining this CE markis the fruit of a long and hard effort by our teams, in collaboration with ourcustomers and partners. We are proud of this collective success, which isproof of our dynamism and our ability to adapt to regulatory changes.’
As a reminder, medical devices (MD) cannot be released inEurope without CE marking.
All MD manufacturers must implement a qualitymanagement system within their organisation. In July 2024,Promepla S.A.M. renewed its ISO 13485 certificate, aguarantee of compliance and continuous improvement.
In order to affix the CE mark, an MD manufacturer must also compile technicaldocumentation (TD) that meets the requirements of European regulations (MDR) anddemonstrates the safety and performance of its products. Depending on the risk class of thedevice, a notified body, designated in accordance with the Regulation, assesses the TD with aview to issuing the CE marking certificate, proof of the product’s conformity.
Kim Herbert, new Quality & Regulatory Affairs Director of Promepla,comments: ‘On the strength of our experience in Europe and around theworld, our services include assisting our customers with the certificationprocess for Regulation (EU) 2017/745, as well as providing support for theregistration of medical devices outside the European Union.’
