Regulation · 12 November 2026
MDR and private label: which documents should you review before a partnership?
Before marketing a medical device under your brand, link each document to a specific product and market. Private label describes a commercial offering; it does not, by itself, define regulatory responsibilities.
Identify the product and the parties involved
To prepare a regulatory discussion, gather the device name, reference, intended purpose and proposed country of sale. Add the identities of the companies that will manufacture, import or distribute the product. This initial record avoids comparing documents covering different situations.
In VITROBIO's offering, the laboratory remains the legal manufacturer and the partner markets the product under its own brand as distributor. This arrangement is explained in the VITROBIO FAQ. It should be reflected consistently in project agreements and documents.
Clarify marketing under another brand
Article 16 of the MDR covers, among other matters, situations where a distributor or importer markets a device under its own name. It provides a specific case where an agreement maintains the manufacturer's identification on the label and its responsibility under the regulation. The Commission also explains that this agreement does not transfer UDI assignment, the unique device identifiers, to the distributor. See MDCG 2018-6 and MDCG 2026-5.
The question at the start of the project is therefore straightforward: who retains each responsibility, and how is this arrangement documented? The answer should precede finalisation of the carton.
Organise the document review
European Regulation 2017/745 provides for an EU declaration of conformity and, depending on the applicable procedure, notified body involvement. It also governs labelling, information for use and clinical evaluation. A logo alone is not enough to verify a product's status. Review the documents covering it. MDR regulation text.
Prepare a list of questions to make the review effective:
- Which document covers the exact product being considered?
- Which names, codes and versions identify it unambiguously?
- Who confirms the scope and validity of the documents presented?
- Which version of the instructions and packaging forms the project basis?
- Which data can be shared with your team, and under what conditions?
This method helps coordinate commercial, regulatory and design teams. It avoids treating packaging, product reference and dossier separately when they must remain consistent.
Prepare commercial content too
Article 7 of the MDR prohibits misleading claims about a device's intended purpose, safety and performance. Texts for the website, sales teams and launch materials must therefore remain consistent with the product concerned. MDR, Article 7.
A useful working question is: which document supports this exact wording? Our article on local physical action explains why a technology's mechanism and a product's clinical results should be presented separately.
Turn the review into a practical project
For an international project, clarify the procedures specific to each destination. A European dossier should not be presented as universal marketing authorisation.
Prepare your discussion with our guide to choosing a private-label manufacturer, then tell VITROBIO about your markets. This article provides general guidance; the applicable pathway must be determined for each project with the relevant regulatory teams.