I think Anne-Sophie is right. For the sake of clarity, I want to add the following.
Just have a look in ISO 14155:2011 "Clinical investigation of medical devices for human subjects - Good clinical practice", definitions 3.2 (adverse event), 3.36 (serious adverse device effect), 3.37 (serious adverse event), and 3.42 (unanticipated serious adverse device effect).
And have a look in MEDDEV 2.12-1 (rev 8 of January 2013) "Guidelines on a medical devices vigilance system". § 2 (Introduction) starts with saying that "These guidelines describe the European system for the notification and evaluation of INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL DEVICEs, known as the Medical Device Vigilance System". And look in § 4 for the definitions of incident (4.10) and FSCA (4.6).
Nice clarification, Carrie ! I just want to make a comment about having one procedure covering reporting obligations for multiple regions (jurisdictions). Over time, on multiple occasions, I have seen citations in FDA Warning Letters for companies that appeared to have one procedure combining language or requirements for multiple regions. This was done in such a manner that FDA felt very uncomfortable with this, fearing that FDA reporting obligations were not assured to be met. The most recent example comes from a Warning Letter to EuroDiagnostica AB (Malmo, Sweden) as per the below link and excerpt from that Letter. So, just make sure your single procedure addressing reporting obligations for multiple regions properly and unambiguously implements the precise wording and requirements from each region.
Excerpt b. The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803.
Hope this helps and with kindest regards,
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