Changing the name, changing the rules: what about white-label medical devices?

Introduction

Under the glare of marketing spotlights, the same device may change its name, logo, or even owner. But behind the scenes of Regulation (EU) 2017/745 (MDR), this change in appearance comes with a very different script: a shift in responsibilities.

The “white-label” model explained

Commercial principle

The so-called “white-label” (or private label) model consists of marketing a product designed and manufactured by one company under the name of another. Practically speaking, an OEM (Original Equipment Manufacturer) designs and produces the device – carrying responsibility for regulatory compliance – while a PLM (Private Label Manufacturer) markets it under its own brand and packaging.

This practice, common in many industries, has also existed in the medical device sector.

However, since the MDR came into force, this approach is much more tightly regulated. Simply adding a new logo or changing the manufacturer’s name on the label now fundamentally alters the regulatory role.

Why this is an issue in medical devices

Under the former Directive 93/42/EEC (MDD), a PLM could rely on the OEM’s CE certificate. The OEM retained technical control and the full documentation, while the PLM marketed the product under its own brand, supported by a confidentiality agreement and a simplified technical file.

This model allowed some actors to sell devices without in-house regulatory expertise, while OEMs could focus on design and manufacturing without handling commercialization. For the end user, the true manufacturer often remained invisible.

The MDR ends this opacity. It clearly redefines the manufacturer as “the natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark” (Article 2).

In other words, as soon as a company markets a device under its own name, it becomes a full manufacturer, with all associated obligations (technical documentation, quality system, etc.).

(See also our article Medical Device Manufacturer: The Starter Pack.)

The MDR’s efforts intent is to strengthen transparency, traceability, and accountability on the European market.

Advice: Changing the label means changing your status. If the name on the packaging or documentation changes, the manufacturer under the MDR changes too.

The MDR Changed Everything

A Manufacturer is still a manufacturer

In short, the entity whose name appears on the device, packaging, or instructions for use is considered the manufacturer, even if it did not participate in designing or producing the device. It is therefore fully responsible for MDR compliance of the device.

There are a few scenarios (Article 16) in which an economic operator may make certain modifications without being considered as a manufacturer, but these exceptions are tightly constrained.

Advice: Always formalize relationships with your partners. A clear contract, a well-drafted quality agreement are the best tools to avoid taking on responsibilities that are not yours.

The compliant options today

Regulation (EU) 2017/745 has overhauled the “white-label” model to clarify, allocate, and reinforce responsibilities among economic operators. While the classic OBL/PLM arrangement no longer exists in its former form, the MDR still allows alternative routes to market a device:

-Classic distribution: the simplest principle. The manufacturer of the device is responsible for regulatory compliance and retains its name and brand on the product labelling. The distributor, meanwhile, is limited to purchasing and reselling the device without making any modifications or appearing on the packaging.
Advantages: straightforward commercial relationship; manufacturer and distributor responsibilities are clear and distinct.
Limitations: no product customization for the distributor; the distributor’s brand/visual identity does not appear on the product.

-Limited white-label resale: a variant of the classic distribution model. The manufacturer remains responsible for regulatory compliance but agrees that the distributor’s name and/or brand may appear on the device labelling, without any transfer of responsibility. In other words, the distributor may request to adapt the device’s name or branding without being considered the legal manufacturer, provided that the original manufacturer approves these changes.
Advantages: enhances the distributor’s brand; visual coherence across the distributor’s range.
Limitations: changes are limited and subject to the manufacturer’s agreement.

-Manufacturing contract: the legal manufacturer designs the device, while a subcontractor manufactures it on the manufacturer’s behalf.
Advantages: the manufacturer does not need to have internal industrial resources for production.
Limitations: the manufacturer remains responsible for regulatory compliance and the product documentation; the control of the subcontractor relies on the manufacturer.

-Full technical documentation sharing: the rarest option. The PLM markets the device under its own brand and becomes the legal manufacturer because the OEM grants access to all product documentation (design, validation, risk management, etc.).
Advantages: design and regulatory documentation efforts are provided by the OEM.
Limitations: full access to documentation is difficult to negotiate due to trade secrets and intellectual property.

Good Practices and Practical Advice

Under the MDR, every economic operator must know exactly what role it plays and which responsibilities it assumes. For more detail, see our article Medical Device Manufacturer: the Starter Pack. A simple contractual misunderstanding can have major consequences.

Frame your commercial relationships: contract, quality agreement, and technical annexes—document everything to protect yourselves in case of disputes.

Clarify roles at contract stage: be vigilant about the allocation of roles and responsibilities. Keep this in mind: if your name is on the label, you are the manufacturer.

Involve your notified body early: your NB can advise on these decisions. Seek their input upstream to avoid heading down the wrong path.

Conclusion – Rebranding under the MDR microscope

Changing a name is no trivial matter and often means changing roles. The MDR has ended the “copy-paste compliance” logic between OEM and PLM. From now on, any actor marketing a device under its own brand becomes fully responsible for its compliance. When anticipated and properly contractualized, this transformation can become an opportunity to structure your quality and traceability – two pillars essential to market trust.

📧 Contact us for digital and personalized support.