Can a company be both importer and distributor under MDR?
It’s quite common in practice for a single company to both bring medical devices into the EU and then supply them directly to healthcare providers or other end customers. This often raises the question: can one company be both the importer and the distributor of a medical device under the Medical Device Regulation (MDR)?
What the MDR says
The MDR makes it clear that the roles of importer and distributor are legally distinct. Article 2(34) defines a distributor as someone other than the importer. That means a company cannot hold both regulatory roles for the same unit of a device.
However, this does not mean that a company is prohibited from performing activities typically associated with both roles. The key is that each product unit must have clearly defined actors in the supply chain, and for each unit, a company can either be the importer or the distributor — not both.
Understanding the activities vs. the roles
In many cases, a company might import a device into the EU, receive it into its warehouse, and then ship it directly to a hospital. While this looks like both importing and distributing, the company is acting solely as the importer for that unit. Once a device is placed on the EU market, any further handling by the importer — including supplying it to the end user — does not change the legal role assigned to that company for that device.
The role of distributor, according to MDR, only applies to entities further down the supply chain who receive devices that have already been placed on the market by someone else.
When a company may have both roles
A company may act as both importer and distributor — but only for different devices. For example, if it imports some devices on its own and also supplies other devices that have been placed on the market by a different importer, then it performs both roles in parallel. But for each specific unit, only one role applies.
How to stay compliant
The most important thing is to identify the role the company performs for each unit and to reflect this clearly in the company’s internal procedures and Quality Management System. There is no need to duplicate documentation or keep separate sets of records unless the company performs both roles for different products. What matters is clarity — who placed the device on the market, and who made it available afterward.
While MDR may evolve in the future to provide more clarity, the current approach to compliance relies on understanding these distinctions and documenting them correctly.
