Furthermore, these guidelines are intended to promote a uniform application and implementation of the Medical Device Vigilance System requirements included in the Medical Device Directives (AIMD, 98/385/EEC; MDD, 93/42/EEC; and IVDD, 98/79/EC).
Revision 7 of the MEDDEV 2.12-1 reflects the position taken by representatives of National Competent Authorities (NCAs) and Commission Services, Notified Bodies, Medical Device Industry representatives, and other interested parties of the Medical Device Sector.
So, what’s new in these Medical Device Vigilance Guidelines?
- During the revision process, international regulatory guidance documents on vigilance and post-market surveillance developed by the Global Harmonization Task Force (GHTF) were considered and transposed into the European regulatory context (e.g. GHTF SG2 document 54: ‘ Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices’, 2006).
- The geographic scope has been extended to include Turkey (see § 3). In the previous version, the scope of the guidelines was limited to the Member States of the European Economic Area (EEA) and Switzerland (see MEDDEV 2.12-1 rev 6, 2009 where Turkey was included as a candidate country).
- Obligations of the European medical device database EUDAMED and its interaction with the Competent Authorities have been outlined and added to this document. For example, the guidelines now include a mandate to utilized EUDAMED for the distribution of National Competent Authorities reports (NCARs) among NCAs and the European Commission.
- A Manufacturer’s Periodic Summary Report Form has been developed (Annex 6). This form can be used by the Manufacturer or Authorized Representative when periodic reporting schemes have been agreed with a National Competent Authority (see § 5.1.2)
- A manufacturer’s Trend Report form has been developed (see §5.1.4; Annex 7).
- Two existent Reports Forms have been 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" (see § 18.104.22.168), has been updated and the following statement has been 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, has been updated to include, in addition to Incidents, specific examples of Field Safety Corrective Actions.
This new version of the MEDDEV Guidelines on a Medical Devices Vigilance System will be applicable as of June 15, 2012. A full PDF version of this document can be found on the MEDDEV website