Such a representative is mandated and acts as your primary contact to carry out your regulatory activities on your behalf under the Medical Device Regulation (MDR).

Note that the person or company who will place your device on the Union market from a third country will be regarded as an importer.

If you are established out of the European Union, the entity who will perform initial placing on the market of your product will be regarded as an importer from the regulatory perspective.

As such, that entity will be expected to fulfill the corresponding obligations such as: verifying that the device is CE marked and has a valid EU Declaration of conformity, ensuring device is properly labeled as per MDR requirements, etc.

As legal manufacturer, you are expected to demonstrate control of your supply chain, notably by clearly identifying the role(s) of your sub-contractors and establishing appropriate controls with them.

“Making available on the market” means a product is made available on the market when it is supplied for distribution, consumption or for use for commercial purposes within the EU, whether it is sold or given for free.

On the other hand, a device is “placed on the market” the first time it is made available.

It’s key to note that a product can only be placed on the Union market once in its lifecycle.

“Putting into service” refers to the stage at which a device is made available to the final user like a hospital, clinic, or patient and is ready to be used for the first time for its intended purpose.

You might also become subject to obligations of manufacturers if you conduct certain activities with that third party’s device, for example:

• If you make the device available under your own name, registered trade name or trademark, outside of an agreement with the manufacturer,
• If you change the intended purpose of the device – make sure to remain in line with the manufacturer’s original intended use, including part of your promotion and advertising activities,
• If you conduct modifications on the device that might affect its regulatory compliance.

It is essential that you determine the scope of activities you perform with the device to fully understand impacts on your responsibilities and obligations.

These agreements allow ensuring roles and responsibilities are well defined within parties and to ultimately maintain regulatory compliance through the supply chain.

As a legal manufacturer, you are ultimately responsible for oversight of your product’s compliance throughout the supply chain, and quality agreements are one way to control the activities that are sub-contracted.

However, the same entity cannot be both importer and the distributor for that specific device.

Similarly, importers may also rely on third parties for transportation services or hold devices on a consignment basis (i.e., third-party logistics provider holding devices at a site, without having legal ownership of those devices). These companies may not be considered an importer either.

While distributors and importers may sub-contract certain activities like storage and transportation, the device remains under their responsibility and there should be a clearly defined agreement between both parties. Importers and distributors shall ensure the storage or transport conditions comply with the conditions set by the manufacturer and that product integrity is maintained, through appropriate oversight and control of their sub-contractors.