1. 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.
  2. 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.
  3. 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.
  4. A manufacturer’s Trend Report form was developed.
  5. Two existing Reports Forms were updated: a) Report Form Manufacturer’s Incident Report and b) Manufacturer’s Field Safety Correction Action Report.
  6. 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.”
  7. 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.