Knowledge · MDR Article 16
MDR Article 16: sterilisation, packaging, relabelling
Whoever sterilises, repackages or relabels finished medical devices becomes a manufacturer themselves.
Article 16 of the EU MDR governs manufacturer status for activities on already finished medical devices: whoever sterilises a device, relabels it, repackages it for sterility maintenance or relabels it in order to place it on the market under their own name becomes a manufacturer themselves — with all obligations of Articles 10 to 16.
The three cases
- Sterilisation of a device to be placed on the market sterile (16.1a)
- Relabelling or repackaging for sterility maintenance (16.1b)
- Repackaging or relabelling to market the device under own name (16.1c)
Exception: trading the unchanged product
Whoever distributes the product unchanged remains a distributor or importer — the extended obligations (ISO 13485 QM, minimum label stock, notification to the manufacturer) do not apply.
Why this matters
Many brand owners believe they are “only relabelling” and carry no manufacturer obligations. Under the MDR exactly those full obligations apply. INOPREX can take on this role for clients.
Frequently asked questions
What does this mean for own brands?
Whoever markets another company’s medical device under their own name is the manufacturer. Alternative: INOPREX takes on the manufacturer role and the client markets the brand.
Applied to your project
We apply these rules directly to your project — from classification to market access. First assessment within two working days.