Reporting deadlines
Answer three short questions and see how many days you have to report an incident or a field action in each market where your device is sold, together with the clause each deadline comes from.
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Real cases are rarely as clean as a list of options. Tell me what happened, and we will work out together what to report, to whom and by when.
The tool shows the regulatory deadline for a typical case. Your own procedure or the authority may expect a faster report. When you are not sure, report on time with what you know and send the rest in a follow-up report.
Pick every market that applies.
The clock starts on the day anyone in your company first learned about the event, not on the day the investigation ended.
after the action starts
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Where is the device on the market?
What happened?
When did your company become aware of it?
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Answer the three questions and your deadlines will appear here, one per market.
Your reporting deadlines
working days (weekends skipped, public holidays not)
calendar days
after the decision to start the action
after you became aware of it
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.