What are the new Medical Devices Vigilance System guidelines?
- During the revision process, international regulatory guidance documents on vigilance and post-market surveillance developed by the Global Harmonization Task Force were considered and transposed into the European regulatory context.
- Obligations of the European medical device database EUDAMED and its interaction with the Competent Authorities were outlined. For example, the guidelines now include a mandate to utilized EUDAMED for the distribution of National Competent Authorities reports among NCAs and the European Commission.
- A Manufacturer’s Periodic Summary Report Form was developed. This form can be used by the Manufacturer or Authorized Representative when periodic reporting schemes have been agreed with a National Competent Authority.
- A manufacturer’s Trend Report form was developed.
- Two existing Reports Forms were updated: a) Report Form Manufacturer’s Incident Report and b) Manufacturer’s Field Safety Correction Action Report.
- The following example of what is not considered to be an incident listed under “Protection against a fault functioned correctly,” was updated and the following statement was added: “An intervention by the user or an immediate remote intervention by the manufacturer allowed the device (analyzer) to resume its function (analysis), resulting in correct results.”
- Annex 1 was updated to include, in addition to Incidents, specific examples of Field Safety Corrective Actions.
A full PDF version of the guideline document can be found on the MEDDEV website.