New Adverse Event Reporting Guidelines for Europe

The European Commission has issued new guidelines for how entities conducting clinical trials should report serious adverse events to appropriate national competent authorities (NCAs).

The new release, MEDDEV 2.7/3, covers pre-market clinical investigations for non-CE marked medical devices as well as for CE marked devices tested for indications beyond which CE marking was ascribed. The guidelines were issued to address requirements of Directive 90/385/EEC’s Annex 7 and Directive 93/42/EEc’s Annex X stating, “All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.”

MEDDEV 2.7/3 identifies the following events as reportable according to the aforementioned Directives:

• Any serious adverse event
• Any Investigational Medical Device Deficiency that could have led to a serious adverse event if appropriate action had not been taken, no intervening action had been taken or if “circumstances had been less fortunate”
• New findings related to previously reported events

Reporting responsibilities fall to clinical investigation sponsors, according to the new guidelines; appropriate adverse events should be reported to all NCAs in whose territories those clinical investigations take place.

In terms of timelines, sponsors must report serious adverse events entailing risk of death, injury or illness to NCAs immediately but no later than two calendar days following awareness of the event. For all other adverse or other events identified in MEDDEV 2.7/3, sponsors have up to seven calendar days to report to their NCAs. Furthermore, the guidelines suggest sponsors deploy systems to enable their clinical investigators to report relevant events to sponsors within three calendar days of their occurrence.

A copy of the reporting form template sponsors should use for submission of events to NCAs is available in the MEDDEV 2.7/3 release.