Who Is the Manufacturer? Economic-Operator Roles in DHT Supply Chains
How provisioning, importing, kitting and modifying a device assign manufacturer, importer and distributor duties — often by operation of law.
REGULATORY OPERATIONSEconomic-operator roles attach to what a party does with a medical device, not to its job title — and in a trial they are inherited by operation of law.
Importing a CE-marked device makes you its importer; distributing it, a distributor; bundling it, the system producer; supplying it under your own name or modifying it, the manufacturer (Article 16). Map the roles on the RIA scoping decision and name a legal entity for each in the contracts before any device moves.
Roles attach to conduct and escalate to manufacturer at two points
Four positions that separate a role map from a job-title list
A vendor that imports, locks down, images or bundles devices with a sensor may already carry importer, distributor or system-producer duties — provided a device is in scope at all.
MDCG 2019-11 Rev. 1 and MDCG 2023-4 decide whether a device is in scope. A CE-marked device used off-purpose as a data tool is not automatically an MDR clinical investigation (Art. 2(45)).
Provisioning, cross-border import, direct-to-participant shipment and leasing each attach a role. The customs importer of record and the MDR importer are different concepts — name both.
In qointa's experience the allocation is absent from sponsor–vendor contracts at trial start, so an FSCA, recall or EUDAMED check reveals roles that were inherited, never allocated.
Six deployment facts, each settled by a contract clause at the start
- 1Name the placing-on-market party for provisioned devices; assign importer and distributor duties in the provisioning SOW.
- 2Designate an importer of record and capture conformity-verification and traceability obligations for imported devices.
- 3Name both the MDR importer and the customs importer for direct-to-participant shipments; require accurate customs declarations.
- 4Assess every modification against Article 16; if triggered, allocate manufacturer duties and QMS coverage.
- 5Allocate the Article 22 statement to a named producer; record the phone or gateway as an 'other product' under Art. 22(1)(c).
- 6Decide the route — Article 62, 74 or 82 — in the RIA for off-purpose use, and assign a re-issue owner who documents the data-wipe.
EU MDR Arts. 2, 10–14, 16, 22, 31, 62–82, Annex XV · MDCG 2021-27 · MDCG 2019-11 Rev. 1 · MDCG 2023-4 · MDCG 2021-23 · MDCG 2021-26 · Decision (EU) 2025/2371 · 21 CFR Part 820 (QMSR) · ISO 13485:2016 · COM(2025) 1023
© qointa 2026 – Public – Uncontrolled when printed · Not legal advice; this summary does not classify any device.
sales@qointa.com · qointa.com
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