19 Jul The European Commission has just issued guidance on the vigilance system for medical devices under the EU medical devices directive
The launch of the surveillance system guidance is linked to a new version of the manufacturer’s incident report (MIR) that will become mandatory in 2020. This new version introduces the use of the International Medical Device Regulators Forum (IMDRF) consensus adverse event terminology and coding and the use of Unique Device Identification (UDI) which we have already discussed in this blog. The new MIR also talks about the unique registration number (SRN), details of which will have to be filled in by the manufacturer in the future Eudamed from January 2020. More details on the use of UDI and SRN can be found here.
This new guidance document from the European Commission on the medical device vigilance system identifies a package of five circumstances for which the competent authority is needed, as well as the four situations in which information should be disseminated among competent authorities, under the National Competent Authority Report (NCAR).
The other clarifications in the new guidance relate to definitions, field safety corrective actions, the content of a field safety notice and the role of a surveillance working group, among others.