March 6, 2023

EU MDR EUDAMED Accuracy Monitoring – Article 31(5)

I’m unaware of any EUDAMED functionality at this time that accommodates the Article 31(5) accuracy monitoring.  With our clients, we’ve embedded procedures for the periodic accuracy check into a “CE Marking” SOP under Article 10(9), third paragraph, indent (a).  Document the periodic accuracy checks via a controlled form or simply by writing a note to the regulatory file.