Vigilance compared to the IVDD

In the In Vitro Diagnostic Directive (IVDD) the concepts of Vigilance and PMS were barely distinguishable. In the European Union Medical Device Regulation (EU IVDR) there is a clear distinction made between; “Vigilance”; the identification, reporting and trending of serious incidents and the conduct of safety related corrective actions, and “Post Market Surveillance” (PMS); the monitoring of information from various sources used to periodically reconfirm that the benefits of the device continue to outweighs its risks. See the separate commentaries on the PMS system, PMS planning and PMS reporting.

The limited vigilance requirements of the original Directive, for the authorities to be informed of incidents (IVDD Article 11 etc.), was quickly considered insufficient by the European Authorities. Guidance was published in MEDDEV 2.12/1: Guidelines on a medical device vigilance system and regularly updated. The most comprehensive update of MEDDEV 2.12/1 was Revision 8, itself updated as recently as July 2019, together with its many standard forms and templates; Manufacturer’s incident report (MIR), Field Safety Corrective Action (FSCA) report, Field Safety Notice (FSN) template and others. It should not be a surprise therefore that the vigilance requirements in the EU IVDR are largely unchanged from those in Revision 8 of MEDDEV. 2.12/1.

The vigilance requirements of the EU IVDR can be found in Chapter VII Section 2 (Articles 82 to 87). The 2-day reporting deadline for serious public health threats remains unchanged from the IVDD, as does the 10 day deadline for reporting a death or a serious health deterioration. However, a 15-day reporting deadline for reporting all other serious incidents replaces the MDD’s 30-day for reporting all other reportable incidents.

The EU IVDR also requires vigilance reporting in the case of a significant increase in the frequency or severity of other incidents. But while trend reporting (Article 83) and analysis (Article 84) may appear to be new when compared to the IVDD, again they were already required by MEDDEV 2.12/1 and have been expected by European Competent Authorities and Notified Bodies for some time.

In practice therefore, the vigilance requirements of the EU IVDR are not new, but rather they bring the European legislation up to date with the current state of vigilance reporting being practiced in the EU, as defined by MEDDEV 2.12/1 Rev 8. The only truly new requirement in the EU MDR related to vigilance, is the requirement to submit vigilance reports to the EUDAMED database (Article 87), rather than to the individual national Competent Authorities as was required under the IVDD. However, until the vigilance module of EUDAMED is available, the national vigilance reporting procedures will remain in place. See the separate page on EUDAMED.