5 docs tagged with "vigilance"

Circumstances in which a serious incident is exempt from mandatory individual reporting to MHRA under UK MDR 2002, and how to document non-reporting decisions.

Practical mechanics of submitting vigilance reports to MHRA — the Submissions portal for manufacturers and UKRPs, the Yellow Card scheme for healthcare professionals and patients, report content requirements, and post-submission follow-up.

Mandatory timeframes for reporting serious incidents and FSCAs to MHRA — 2-day, 10-day, and 30-day reports, initial vs final reports, and how to handle ongoing investigations.

When and how to submit a trend report to MHRA — criteria for a reportable trend, statistical significance, report content, and the relationship to PMS and PSURs.

The events that trigger mandatory vigilance reporting under the UK MDR 2002 — serious incidents, FSCAs, trend reports, and the criteria for determining whether an event is reportable.