Obligations of Importers and Distributors of Medical Devices

The responsibilities of importers of medical devices and in vitro diagnostic devices are outlined in Article 13 of the MDR and IVDR regulations. Article 14 specifies the requirements for distributors of medical devices. Additionally, in certain circumstances, importers and distributors may assume manufacturer responsibilities as indicated in Article 16 of both regulations.

The obligations of importers and distributors of medical devices include:

• Verifying the accuracy of medical device labeling.
• Ensuring the device is registered in the EUDAMED database.
• Providing their identification details on the product’s entry, packaging, and label (importers).
• Ensuring proper storage and transportation conditions.
• Maintaining traceability of all entities involved in the supply chain.
• Properly handling nonconforming products.
• Keeping a register of complaints and notifications.
• Collaborating with relevant entities and authorities.

We can support you in evaluating information intended for users such as instructions, labels, and packaging.

Verification of Product Labeling

The product should bear a CE marking and confirmation of an EU declaration of conformity. While the manufacturer is responsible for this, importers and distributors must ensure its presence before introducing the product to the European Union market.

Importers and distributors should retain copies of the declaration of conformity provided by the manufacturer, along with any amendments and additions. These records must be kept for a minimum of 10 years after the last device covered by the declaration was placed on the market.  For implants, the records should be kept for a minimum of 15 years.

Importers are responsible for including their data on the device, packaging, or accompanying label. These details should enable clear identification of the importer and facilitate direct contact with them. The information should be legible and must not obscure any information on the label provided by the manufacturer.

For products intended for use by laypersons, labels and instructions for use should be available in Polish. The device interface should also be in Polish or consist of universally understood symbols or codes. English interfaces are permitted if all symbols and commands are explained in the instructions.

Verification of Device Registration in the EUDAMED System and Completion of Entry Data

Manufacturers are required to generate a Unique Device Identification (UDI) code for their products, which should be displayed on the device label and packaging. Importers must check if the product is registered in the EUDAMED system before introducing it to the market. Importers also need to provide their data in the system.

Within 7 days of importing each device, distributors must enter the Basic-UDI code, manufacturer’s name and address, as well as the type and trade name of the device, system, or procedure pack in the system.

We can provide assistance with the product notification or registration processes.

Storage and Transportation Conditions

The conditions for storage and transportation of devices are determined by the medical device manufacturer. Importers and distributors have the responsibility to adhere to these conditions to ensure the devices maintain their durability, expected quality, and properties. This is crucial for the proper functioning of the devices and to minimize risks to users.

Identification of Stakeholders in the Supply Chain

In addition to completing data in the EUDAMED database, importers and distributors must maintain records to identify every economic operator who supplied them with a device. They are also responsible for identifying any entities, public health institutions, or health professionals to whom they have directly supplied devices within a period of 10 years (15 years for implants). This information must be provided to relevant authorities upon request.

We can support you in evaluating information intended for users such as instructions, labels, and packaging

When Importers and Distributors Assume Manufacturer Responsibilities

Importers or distributors take on the obligations of a manufacturer in the following situations:

• They make a product available on the market under their own name, trademark, or registered trade name, even if they do not manufacture it, as long as the manufacturer’s data is not present on the product label.
• They modify the intended purpose of a product that is already on the market or in use.
• They modify the product already placed on the market in a way that could impact its compliance with regulatory requirements.

However, this does not include the release or translation of information provided by the manufacturer for a product already on the market, nor does it include the provision and translation of information or changes to the outer packaging necessary to market the product in a relevant member state.

Distributors and importers are required to establish a quality management system to ensure reliable and up-to-date translations. They must also ensure that any repackaging does not compromise the original condition of the product and that the new packaging is free from defects. They should notify the manufacturer and the authority in the member country at least 28 days before making the modified product available on the market.

Implementation of Quality Management System by Importers and Distributors

To ensure compliance with regulatory requirements and the supply of medical devices that meet regulations, importers and distributors often choose to implement a quality system, most commonly ISO 13485. A well-implemented quality system ensures proper identification of suppliers and customers, appropriate handling of non-conforming or defective products, and ongoing modification of procedures. It also ensures the maintenance of necessary documentation, with strict control over any nonconformities and changes made.

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