Launch, and the obligations that begin at approval
“We are approved. What now — and what am I suddenly responsible for that I was not before?”
Approval is a transition, not a finish. A set of continuing obligations begins the day the product reaches a user: complaints have to be handled, adverse events reported on a clock, changes controlled, and the record kept in a state that survives an inspection that will now certainly happen.
WHAT THIS IS NOT
Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.
ARE YOU HERE?
- Approval or clearance is granted or imminent
- The organisation is built for development and is about to need a different set of processes
- Nobody currently owns complaint handling or safety reporting because there has been nothing to handle
WHAT TO DECIDE NOW
- Who owns complaint intake and safety reporting, named and resourced, before the first one arrives
- What the reporting clocks are for your product and market, and how a report reaching any employee reaches that person the same day
- Which changes will require notification or approval before implementation, so the first improvement is not also the first violation
START KEEPING THESE RECORDS NOW
- Complaint records from the first one, complete and including the ones resolved as user error, because the pattern is the signal
- The distribution record, in enough detail to recall a defined batch rather than everything
- Post-approval change history against what was approved, which is what an inspection reconciles
THE PROBLEM THIS ANSWERS
Approval creates obligations — complaint handling, vigilance, change control, distribution — that arrive simultaneously in an organisation that has never run any of them and has assigned none of them.
What it costs: The first real postmarket signal is handled by whoever notices it, which is the pattern regulators find when they ask how a problem reached the people who could act on it.
NOT YET MEASURED — Postmarket-shaped queries arriving on the startup guide rather than on the discipline pages.
WHERE THIS GOES WRONG
- Treating an adverse event report as a customer-service matter. The clock usually starts at the organisation’s first awareness by anyone, not at the safety team’s.
- Improving the product without change control. Manufacturing differently from how you were approved is a compliance problem even when the change is better.
- Reading a period of no complaints as evidence of safety. Early silence is more often evidence that nobody has been asked.
WHAT THIS DOES NOT ANSWER
- Which postmarket studies or surveillance commitments attach to your approval, which are specific to it
- How your obligations differ in each market you enter, which do not harmonise as much as the technical requirements do
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