A distributor verifies conformity, not re-runs it

Four checks, not a general duty of care

MDR Article 14(2) is specific in a way distributor obligations are often assumed not to be. Before making a device available on the market, a distributor has to verify that all of the following are met: the device has been CE marked and its EU declaration of conformity has been drawn up; the device is accompanied by the information the manufacturer owes it under Article 10(11) — labelling and instructions for use, in the required form; for an imported device, the importer has complied with its own Article 13(3) obligations; and, where applicable, a UDI has been assigned by the manufacturer. That's the entire list. A distributor compliance procedure that folds this into a vague “confirm the device is compliant” step has replaced four checkable items with one that can't actually be checked off.

Sampling is allowed for three of the four, not all four

Article 14(2) also permits a distributor to meet points (a), (b), and (d) — CE marking and the declaration of conformity, the accompanying information, and the UDI — through a sampling method representative of the devices it supplies, rather than inspecting every unit. Point (c), the importer's own Article 13(3) compliance, is left out of that allowance. A distributor's verification procedure that applies one sampling rate uniformly across all four checks has extended a permission the regulation only wrote for three of them.

What ‘verify’ actually requires, per the Court

How far that verification has to go was an open question until the Court of Justice of the European Union answered it directly. In its judgment of 4 June 2026 in Case C-10/24 (Dürr Dental), on a reference from Germany's Bundesgerichtshof, the Court held that a distributor's Article 14 duty is a duty of due care, not a re-run of the manufacturer's own conformity assessment: it's the manufacturer that applies the CE marking and signs the declaration of conformity, and bears primary responsibility for the device's conformity. A distributor has to check, on the basis of information available or readily accessible to it, that the CE marking and declaration of conformity manifestly relate to a device within the MDR's scope — not independently verify the device's risk classification is correct. The Court described this as a coherence check: a breach of the duty only arises where a classification error is obvious, not where it's merely arguable. A distributor doesn't have to become a second reviewer of a manufacturer's classification logic to satisfy Article 14 — it has to notice when the paperwork in front of it plainly doesn't add up.

A tip changes what ‘reason to believe’ requires

The Court's judgment also addressed what happens once a distributor has a reason to look closer — a competitor's warning letter, for instance, can be enough to trigger the question. Putting the concern to the manufacturer and receiving an answer that the device is compliant is enough to discharge the distributor's duty, unless the manufacturer's position is plainly untenable on its face. A distributor isn't required to keep investigating past a manufacturer's considered response; it's required not to accept an answer that obviously doesn't hold up.

What happens when the check fails

Article 14(4) sets the consequence once a distributor considers, or has reason to believe, a device isn't in conformity: it can't make the device available until it's been brought into conformity, and it has to inform the manufacturer, the manufacturer's authorised representative where one applies, and the importer. Where the device presents a serious risk or is falsified, that notification extends to the competent authority of the distributor's own Member State. For a device already placed on the market that later raises the same concern, the obligation to inform runs immediately, and the distributor has to cooperate with the manufacturer, authorised representative, importer, and competent authorities on whatever corrective action — bringing the device into conformity, withdrawal, or recall — the situation calls for.

Where this meets the rest of the file

Article 14's UDI check closes on the same identifier this blog has already traced through downstream records — the distributor is one more point where that identifier either resurfaces correctly or doesn't. And the distributor's role sits alongside, not inside, the authorised representative's own separate obligations under Article 11 — a different actor with a different duty list, easy to conflate with the distributor's four-item check but answerable to a different part of the regulation entirely. A distributor verification log built around Article 14(2)'s actual four points, the sampling carve-out, and the coherence-check standard the CJEU now sets is previewed in the launch catalog. If your program runs this check differently, the shelf takes that correction directly.