CE Mark Regulation EU 2017/745 (Medical Device Regulation)

Supports manufacturers, distributors, and importers of Medical Devices (MDs), in the CE marking process taking into account Article 20 of Regulation EU 2017/745 (Medical Device Regulation - MDR). In this sense, IPN supports the implementation and review of the Quality Management System (QMS), preferably according to ISO 13485, together with the elaboration or revision of the Technical Documentation (TD) of the device (under Annex II and Annex III of MDR). CE marking comprises, among others, risk management and clinical and biological evaluation. IPN also assists in obtaining the UDI and registration within EUDAMED and, depending on the device classification, submission of the certification request to a notified body. If an authorized representative is required, IPN also refers possible entities to the company.