Essential requirements for importers and distributors under MDR and IVDR

In the European Union, the roles of importers and distributors in the medical device supply chain are distinct, yet both are important in ensuring that medical devices meet regulatory requirements before reaching end-users. Understanding the difference between these two roles is key to complying with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Importers are defined as any natural or legal person established within the EU who places a device from a third country (non-EU country) on the EU market. In other words, importers are responsible for bringing medical devices from outside the EU into the Union market.

Distributors, on the other hand, are defined as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service. Distributors do not bring devices from outside the EU; instead, they handle products that are already within the EU market, ensuring that the devices are appropriately stored, transported, and made available to healthcare providers or end-users.

If a medical device is manufactured outside of the EU, the entity responsible for bringing it into the EU market is classified as an importer. In other words, it is impossible for a device produced outside the EU to enter the EU market without an importer.

On the other hand, the importer can also act as a distributor, and this dual role is quite common in the market. In this scenario, the same entity manages both the importation of the device into the EU and its distribution within the market. However, regardless of whether the importer also acts as a distributor, the essential point remains: any device that appears on the EU market must have an importer.

Obligations of importers

Importers of medical devices in the EU have several key obligations under the MDR to ensure compliance and safety. They must only place devices on the market that conform to the regulation, verifying that the device is CE marked, the EU declaration of conformity is available, and that a manufacturer and authorized representative are properly designated. Importers must also ensure that the device is correctly labeled, accompanied by instructions for use, and, where applicable, assigned a UDI.

Importers are required to display their name, trade name, and address on the device, packaging, or accompanying documents, and ensure that any additional labels do not obscure the manufacturer’s information. They must also verify that the device is registered in the electronic system and add their details accordingly.

While the device is under their responsibility, importers must maintain proper storage and transport conditions to preserve compliance with safety and performance requirements. They must keep a register of complaints, non-conforming devices, recalls, and withdrawals, and share relevant information with manufacturers and authorized representatives.

Importers must immediately inform the manufacturer, authorized representative, and competent authorities if a device does not comply with the regulation or presents a serious risk. They are required to cooperate in corrective actions, including recalls or withdrawals, and provide authorities with necessary samples or access to the device. Additionally, they must forward any incident reports received from healthcare professionals, patients, or users to the manufacturer and authorized representative and keep necessary documentation, such as the EU declaration of conformity, for the required period.

Obligations of distributors

Like importers, distributors of medical devices in the EU have their obligations to ensure compliance with the MDR. They must act with due care, verifying that devices are CE marked, accompanied by the necessary documentation, and that importers have met their obligations. Distributors must ensure proper storage and transport conditions as specified by the manufacturer to maintain device conformity.

Before making devices available on the market, distributors must confirm that the device meets all regulatory requirements. If a device is found to be non-compliant or poses a serious risk, distributors must halt its distribution, inform the manufacturer, authorized representative, and importer, and notify the competent authorities if necessary. Distributors are required to maintain records of complaints, non-conforming devices, recalls, and withdrawals, and provide this information to relevant parties upon request.

Additionally, distributors must cooperate with competent authorities, providing any necessary documentation and access to devices to demonstrate compliance. They must also forward any incident reports from healthcare professionals, patients, or users to the manufacturer and other relevant parties, ensuring prompt communication and action to address potential risks.

Multiple importers of a device model from one manufacturer

A medical device may have multiple importers within the EU, as the obligations of device importers apply to any entity that meets the definition outlined in Article 2(33) of the MDR or Article 2(26) of the IVDR. Importantly, the concept of placing on the market refers to each individual device rather than the type of device. This means that individual devices of the same model can be placed on the market by different natural or legal persons, each acting as an importer and responsible for fulfilling the regulatory requirements specific to importers.

This situation can occur even if another importer already exists within the EU for the same device model. However, it is not possible to have multiple importers for the same individual device; each device can only have one importer responsible for its initial placement on the EU market. Therefore, while multiple entities can act as importers for the same type of device, each individual device is linked to a single importer when it enters the market.

Indicating the importer on the device, its packaging or accompanying documentation

Importers are responsible for ensuring that their information is included on the device, its packaging, or in the accompanying documentation, as required by Article 13(3) of the MDR and IVDR. This can be done directly by the importer or subcontracted to another party; however, the importer remains fully responsible for the correct execution of this obligation, regardless of how it is carried out. Distributors, on their part, are responsible for verifying that the importer's details have been properly included before further making the device available on the market, as specified in Article 14(2)(c) of the Regulations.

It is important to note that including the importer’s details before the device physically enters the EU is not mandatory. However, these details must be present on the device (or its packaging or accompanying documents) when the device is first placed on the EU market. Therefore, the absence of the importer’s information at the point of customs control does not constitute non-compliance with the Regulations, as long as the details are correctly added before the device is officially made available within the Union.