Since the Medical Device Regulation (Regulation (EU) 2017/745 (MDR)) became applicable on May 26, 2021, special requirements have applied to importers placing products on the market and distributors making products available on the market. Typically, our blog is directed towards manufacturers of medical devices, but today we focus on these two other economic operators, who are also impacted by the MDR.

Before diving into the specific requirements, it is essential to clarify the roles of the different economic operators. Are you aware of your role(s)? Do you know the implications? After clarifying the roles, we will detail the obligations you must fulfill as an importer and/or distributor, and we will conclude with an overview of what to consider when making changes to a product. Let’s begin:

Importer or Distributor – or Both?

According to Article 2 of the MDR, an importer is "any natural or legal person established within the Union that places a device from a third country on the Union market".

A distributor is defined as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a product available on the market, up until the point of putting into service." Therefore, a distributor always deals with products that have already been placed on the market.

IMPORTANT: These definitions apply to the devices a company imports or makes available. It is possible for an organization to be a manufacturer for certain products, an importer for others, and a distributor for yet another set of products. Be aware of your respective role and ensure that you immediately establish the necessary prerequisites to fulfill this role!

What Must Importers Be Aware Of?

EUDAMED Registration for Importers

Not every economic operator is required to register. The obligation to register in the European Database on Medical Devices (EUDAMED) applies to importers, but not to distributors.

Please note: If your organization is already registered as a manufacturer, but also acts as an importer, you must register in this role as well.

Regarding the timing of the registration obligation, the European Commission updated the schedule for the phased introduction of EUDAMED in July 2024 due to the entry into force of Regulation (EU) 2024/1860. As a result, registration will be mandatory from January 2026, and, according to MDCG 2021-25, this also applies in principle to importers of legacy devices.

Verification Obligations

For devices under the MDR, importers may only place these devices on the Union market if they actually meet MDR requirements. This includes verifying whether the product is correctly CE-marked, whether instructions for use (IFU) are provided, whether an EU Declaration of Conformity has been issued, and whether the manufacturer and authorized representative (EC-REP) have been identified.

Once the requirements for UDI marking become mandatory, importers must ensure that the product is assigned a UDI.

Before products are placed on the Union market, importers must verify whether the manufacturer has registered the product in EUDAMED.

As with the registration of economic operators mentioned above, current plans (as of July 2024) foresee that product registration in EUDAMED will become mandatory in January 2026 and must be completed by July 2026.

Information and Cooperation Obligations

If an importer suspects that a product does not meet MDR requirements, they must inform the manufacturer. The competent authority must be notified in cases of suspected counterfeit products or if a serious risk associated with the product is suspected. If a notified body is involved in the product''s conformity assessment, it must also be informed.

If the importer receives information about suspected incidents involving the product, they must immediately forward this information to the manufacturer and the authorized representative.

If risk mitigation or prevention measures are necessary, the importer must cooperate with the competent authorities and make the product available to them or grant access to the product.

Complaint Registry

Importers must maintain a record of complaints, product recalls, and product withdrawals and share this information with the manufacturer, authorized representative, and, if applicable, distributors.

Labeling Obligations

The importer must provide their name, registered trade name or trademark, and address on the product, its packaging, or in an accompanying document.

Record-Keeping Obligations

Importers must retain copies of the EU Declaration of Conformity and any relevant amendments or supplements in accordance with applicable retention periods.

What About Legacy Devices?

In line with MDR post-market surveillance requirements, which also apply to legacy devices, the information and cooperation obligations, as well as the complaint registry requirement, also apply to legacy devices placed on the market by the importer. (MDCG 2021-25, section 2 "Application of other MDR requirements to 'legacy devices'")

What Must Distributors Be Aware Of?

Verification Obligations

Distributors may only make products available on the market under certain conditions. They must verify that the CE marking is present, that an EU Declaration of Conformity has been issued, that accompanying product information is available, and, in the case of imported products, that the importer has provided the required details.

Once UDI marking requirements become mandatory, distributors must verify that a UDI has been assigned to the product.

Distributors must conduct these verifications, at least on a sampling basis, for the products they supply.

Information and Cooperation Obligations

If a distributor has reason to believe that a product does not meet the requirements, they must immediately inform the manufacturer and, if applicable, the authorized representative (EC-REP) and the importer. The distributor cooperates with the manufacturer (and, if applicable, the authorized representative and importer) and the competent authority to ensure that the necessary corrective actions are taken.

If the distributor believes or has reason to suspect that a product poses a serious risk, they must immediately inform the competent authorities in the member states where the product was made available, providing detailed information on the non-compliance and any corrective actions already taken.

Reports of suspected incidents must be promptly forwarded by distributors to the manufacturer and, if applicable, the authorized representative and importer. Distributors must maintain a registry of complaints, non-compliant products, recalls, and withdrawals and keep the manufacturer and, if applicable, the authorized representative and importer informed.

To mitigate risks, distributors must provide the competent authority with the information or documentation they hold or provide product samples or grant access to products upon request.

Distributors should understand that these information and cooperation obligations also apply to legacy devices with which they trade.

Caution with Device Modifications!

Importers and distributors must be aware that modifications to devices that have undergone a conformity assessment may result in them being classified as manufacturers in their own right, making them fully legally responsible for the product. This applies to both MDR products and legacy devices.

Such modifications include:

• Making a device available under their own name, trade name, or trademark.
• Changing the intended purpose of a device already placed on the market or put into service.
• Modifying a device already placed on the market or put into service in a way that could affect the device’s compliance with applicable requirements.

Which Changes Can Be Made Without Becoming a Manufacturer?

The MDR provides detailed guidance on this. The following activities do not make an importer or distributor a manufacturer:

• Providing translations of the manufacturer’s information on a product already placed on the market and additional information required for marketing the product in a specific Member State.
• Changing the outer packaging of a product already placed on the market, including changing the package size, if repackaging is necessary to market the product in a specific Member State and is done under conditions that ensure the original product condition is not affected.

When importers or distributors carry out these activities for MDR products or legacy devices, they must indicate these actions on the product or accompanying documentation and provide their name, trade name, or trademark, and address.

Planning Changes to a Product? Only with a Quality Management System!

For those activities that do not make an importer or distributor a manufacturer, a quality management system is required (unless these activities involve legacy devices, in which case this requirement is waived according to MDCG 2021-25, Section 2). The system must ensure that translations are accurate and that the original product condition is preserved, even when changes are made to the product packaging. Additionally, the quality management system must ensure that importers or distributors are informed about the manufacturer's safety-related corrective actions.

Informing the Manufacturer and Competent Authority

Activities within the scope of the quality management system must be reported to the manufacturer and the competent authority (of the EU Member State where the product is to be made available) before the product is placed on the market. Furthermore, the importer or distributor must obtain certification from a notified body confirming that the quality management system meets the applicable requirements. This certificate must be submitted to the relevant competent authority.

How Can We Help?

We hope this text supports you in your regulatory compliance efforts. If you are uncertain whether you are fulfilling your role as an importer or distributor correctly, or if your planned changes to the product might assign you a new role, feel free to contact our author directly. We welcome an informal exchange with you! Of course, if you are a manufacturer or have questions regarding the role of an EC-REP, we are also happy to assist. Just send us a short message via our contact form.