The legal framework of our device vigilance services for medical devices marketed within the EU is provided by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including their implementing and delegated acts, as well as applicable MDCG guidance documents, including those related to vigilance, serious incident reporting, field safety corrective actions (FSCAs), trend reporting, and the use of EUDAMED.
For devices placed on the market under Directives 93/42/EEC, 90/385/EEC, and 98/79/EC, the vigilance requirements of the MDR and IVDR apply.
Furthermore, applicable national legislation and competent authority requirements of the respective EU Member States form part of the framework for the conduct of our device vigilance activities.
In accordance with the gradual roll-out of EUDAMED and until the vigilance module becomes available and mandatory, vigilance reporting is performed through the applicable national competent authority channels.