Relabeling a device doesn't make you its manufacturer

A distributor that relabels a device's packaging to add a required translation, and a distributor that puts its own trademark on a device sourced from someone else, look like the same kind of activity from the warehouse floor. Article 16 of the EU MDR treats them as two different thresholds with two different consequences. One triggers a defined, survivable compliance regime that leaves the distributor a distributor. The other turns the distributor into the legal manufacturer of record, with everything that role carries under the Regulation.

Putting your name on it is the higher bar

Article 16(1) sets the default rule plainly: a distributor, importer, or other person who makes a device available under its own name, registered trade name, or registered trademark assumes the full obligations of a manufacturer under the MDR — technical documentation, conformity assessment, vigilance, the complete list. The one way around that default is a written agreement with the actual manufacturer under which the manufacturer stays identified as such on the label and remains responsible for meeting the Regulation's manufacturer obligations itself. Without that agreement, branding the device as your own is the whole trigger; nothing else about how the product moved through the supply chain, or how much of it the distributor actually touched, matters.

Repackaging and translating run on a narrower rule

Article 16(2) carves out a lower-consequence path for activities that stop short of rebranding: translating the label and instructions for use, repackaging into a different pack size, or relabeling for the destination market, carried out under conditions that leave the device's original condition unaffected. A distributor or importer working this path doesn't become the manufacturer. It stays a distributor, subject to the same obligations this blog has already covered for a distributor that touches nothing about the device at all.

The carve-out comes with its own paperwork

Article 16(2)'s lower threshold isn't unconditional. The distributor or importer has to run the repackaging, relabeling, or translation work under a quality management system covering it; notify the original manufacturer and the competent authority of the Member State at least 28 days before placing the relabeled device on the market; and, on request, produce a sample or mock-up of the relabeled device, translated label included. Where the activity touches a sterile device, that quality system has to show the sterile barrier itself survives the repackaging intact, not just that the outer carton looks undamaged — a narrower version of the same barrier-versus-process question this blog has already covered for packaging validation generally. A notified body has to certify the quality management system within the same 28-day window before the device can move. None of that paperwork attaches to Article 16(1)'s branding trigger — it exists because paragraph 2 is granting an exception, not restating the default.

The manufacturer still has to be findable

Even inside the Article 16(2) carve-out, the original manufacturer's name has to stay identifiable on the label — the distributor's own name, activity performed, and contact details go alongside it, not in place of it. That's the detail an own-brand arrangement is specifically built to avoid, and it's why an importer's own obligations running past the point of sale look different depending on which threshold applies: only the Article 16(1) route lets the original manufacturer's identity disappear from the label a buyer actually sees.

Where this meets the file

A supply-chain file needs to record which Article 16 threshold each private-label or repackaged product actually crossed — the branding trigger in paragraph 1, or the narrower repackaging-and-translation path in paragraph 2 — along with the 28-day notice date and the certificate reference where one applies, rather than a single own-brand flag that collapses two different obligations into one. An Article 16 classification worksheet built around that distinction is previewed in the launch catalog. If your program draws the line differently, the shelf takes that correction directly.