Unacceptable risk gets Article 95, not Article 97

Article 94 is the evaluation, not the verdict

Article 94 covers a device a competent authority suspects of presenting a risk: before anything else happens, the authority carries out an evaluation of the device against the Regulation's requirements, gathering the information it needs to decide what kind of problem it's actually looking at. Nothing about Article 94 itself compels a manufacturer to do anything yet — it's the fact-finding step that determines which of the two enforcement articles that follow actually applies, and a device can sit inside an open Article 94 evaluation without yet owing any corrective action at all.

Unacceptable risk routes to Article 95

Where that evaluation finds a device presents an unacceptable risk to health or safety, Article 95 requires the competent authority to act without delay: it requires the manufacturer, its authorised representative, and every other relevant economic operator to take appropriate, duly justified corrective action bringing the device into compliance, and it can restrict the device's availability, subject it to specific requirements, withdraw it from the market, or order a recall, within a period the authority itself defines. The authority also notifies the Commission and the other Member States of the measures taken — an unacceptable-risk finding under Article 95 doesn't stay contained to one national market or one economic operator's own file.

Non-compliance without unacceptable risk routes to Article 97

A device can fail to meet the Regulation's requirements without clearing that unacceptable-risk bar at all — incomplete labeling, a technical-documentation gap, a UDI that was never properly registered. Article 97 covers exactly that case: the competent authority requires the relevant economic operator to bring the non-compliance to an end within a reasonable, clearly defined period proportionate to the non-compliance itself, without invoking the market restrictions Article 95 authorizes immediately. Only if the operator misses that window does Article 97 escalate to the same kind of restriction, withdrawal, or recall Article 95 can order from the outset — the grace period is the entire difference between the two articles, not a lighter version of the same procedure.

The manufacturer's own nonconformance grading doesn't decide which article applies

A manufacturer's internal quality system runs its own severity grading on a nonconforming product long before any competent authority gets involved — this blog has already covered what that record has to decide on its own terms. That internal grading doesn't transfer onto the Regulation's own fork. A manufacturer that classified an issue as minor in its own file can still find a competent authority routing the same device through Article 95 rather than Article 97, because the authority's unacceptable-risk finding is its own determination, reached under its own evaluation, not an import of whatever severity label the manufacturer's CAPA record already assigned.

Where this meets the file

A market-surveillance tracker needs the Article 94 evaluation logged as its own event — which authority opened it, and against what suspected risk — kept separate from whichever article the authority ultimately invokes: an Article 95 corrective-action order, with its Commission and Member State notification, or an Article 97 non-compliance period, with its own proportionate deadline. Collapsing both into one “regulator contacted us” row loses the fact that decides how much time the file actually has left. A market-surveillance response worksheet built around that three-part structure, alongside the field safety notice this blog has already covered and the SSCP's own public-facing duty, is previewed in the launch catalog. If your program has run an Article 95 or Article 97 response and found gaps this one misses, the shelf takes that correction directly.