Importer Obligations for Medical Devices Under MDR Article 13

This document outlines the mandatory obligations for medical device importers under Regulation (EU) 2017/745, the Medical Device Regulation (MDR). Importers play a crucial role in the supply chain, acting as the interface between third-country manufacturers and the European market. Strict adherence to these requirements is essential for maintaining product safety and regulatory compliance.

#Definition of an Importer

Under Article 2(14) of the MDR, an 'importer' is defined as any natural or legal person established within the Union who places a device from a third country on the Union market. This definition distinguishes importers from distributors, who only make devices available on the market after they have been placed there. The importer's establishment within the EU is a key criterion.

#General Obligations of Importers

Article 13(2) of the MDR stipulates several key responsibilities that importers must fulfil before placing a device on the market. These obligations are designed to ensure that devices originating outside the EU meet the stringent safety and performance requirements of the Union.

#Verification of Manufacturer Compliance

Before placing a device on the market, importers must verify several aspects of the device and its manufacturer. This verification includes confirming:

• The device has been CE marked and an EU declaration of conformity has been drawn up (Article 13(2)(a) MDR).
• An EU authorised representative has been designated by the manufacturer, as required by Article 11 MDR (Article 13(2)(b) MDR).
• The manufacturer is identified on the device or its packaging by name, registered trade name or registered trade mark, and the address at which they can be contacted (Article 13(2)(c) MDR).
• The device bears a UDI (Unique Device Identification) as required by Article 27 MDR (Article 13(2)(d) MDR).
• The device is labelled in accordance with Article 10(11) MDR and accompanied by instructions for use in accordance with Article 7 MDR (Article 13(2)(e) MDR).

If an importer has reason to believe that a device is not in conformity with the MDR, they must not place the device on the market. They must inform the manufacturer and the authorised representative, and the competent authority of the Member State where they are established (Article 13(3) MDR).

#Labelling and Importer Information

Importers must indicate their name, registered trade name or registered trade mark, and their registered place of business address on the device, its packaging, or in an accompanying document. This information must allow for their contact. This requirement applies unless the importer has already provided this information to the manufacturer and the manufacturer has incorporated it into the device labelling (Article 13(4) MDR). This ensures traceability and accountability within the supply chain.

#Storage and Transport Conditions

Importers must ensure that, while a device is under their responsibility, storage and transport conditions do not adversely affect its compliance with the general safety and performance requirements set out in Annex I of the MDR. This includes adherence to conditions specified by the manufacturer (Article 13(5) MDR).

#Quality Management System

Although not explicitly stated as a general obligation for all importers to implement a full quality management system under Article 13 MDR, maintaining adequate procedures to address their responsibilities is critical. This includes processes for device reception, storage, and traceability.

#Post-Market Responsibilities

Importer obligations extend beyond placing the device on the market, encompassing post-market surveillance and corrective actions.

#Complaint Handling and Non-Conforming Devices

Importers must keep a register of complaints, non-conforming devices, recalls, and withdrawals. They must inform the manufacturer and the authorised representative of such matters (Article 13(6) MDR). This ensures that any issues identified are promptly communicated and addressed.

#Cooperation with Competent Authorities

Upon request, importers must provide competent authorities with all information and documentation necessary to demonstrate the conformity of a device. They must keep a copy of the EU declaration of conformity and, if applicable, a copy of the certificate issued in accordance with Article 53 MDR for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market (Article 13(7) MDR). This period extends to 15 years for implantable devices.

#Corrective Actions

If an importer considers or has reason to believe that a device they have placed on the market is not in conformity with the MDR, they must immediately take corrective action. This includes withdrawal or recall of the device, as appropriate. They must also inform the manufacturer, the authorised representative, and the competent authorities of the Member States in which they made the device available (Article 13(8) MDR).

#Serious Incidents and Field Safety Corrective Actions

Importers who have received complaints or reports from healthcare professionals, patients or users about suspected serious incidents, must immediately forward this information to the manufacturer and the authorised representative (Article 13(9) MDR). They must also report such incidents to the competent authority of the Member State where they are established. This ensures effective post-market surveillance and vigilance.

#Role in the Supply Chain and Due Diligence

Importers are expected to exercise due diligence in their operations. This includes understanding the specific requirements for the devices they import and the legal landscape of the EU. The obligations placed upon importers are distinct from those of manufacturers and distributors, though collaboration across the supply chain is essential.

Importers should familiarise themselves with the relevant guidance, such as MDCG documents, to ensure a comprehensive understanding of their responsibilities. For instance, MDCG 2021-27 clarifies the role of importers and their interaction with other economic operators.

#Importer vs. Distributor

While both importers and distributors make devices available on the market, their obligations differ significantly. Importers place devices from third countries on the market, taking on a greater responsibility for initial compliance verification. Distributors then make these devices available further down the supply chain. For more information on the distinctions and distributor duties, refer to Distributor Obligations: Verifying Medical Devices Under MDR Article 14.

#Common mistakes in practice

• Insufficient verification prior to market placement: Failing to check the CE mark, EU declaration of conformity, or authorised representative designation as required by Article 13(2) MDR.
• Omission of importer details: Not adding their name and address to the device or its packaging where the manufacturer has not already included it, as per Article 13(4) MDR.
• Lack of proper record-keeping: Not maintaining a register of complaints, non-conforming devices, recalls, and withdrawals as mandated by Article 13(6) MDR.
• Failure to store documentation: Not keeping the EU declaration of conformity and relevant certificates for the required 10 or 15 years as per Article 13(7) MDR.
• Delayed communication of issues: Not immediately informing manufacturers, authorised representatives, or competent authorities about non-conformities, serious incidents, or corrective actions (Article 13(3), 13(8), 13(9) MDR).
• Assuming manufacturer responsibility: Believing that all compliance checks are solely the manufacturer's burden, thereby neglecting the importer's specific duties under Article 13 MDR.
• Inadequate storage and transport conditions: Failing to ensure devices are stored and transported under conditions that maintain their compliance, as required by Article 13(5) MDR.

#Eudamed and Importer Obligations

The European database on medical devices, Eudamed, is a critical tool for all economic operators, including importers. While its full functionality is being progressively implemented, importers will be required to register their data and provide information on devices they place on the market. This includes data points related to UDI, vigilance, and market surveillance. Leveraging platforms that integrate with Eudamed can streamline compliance processes and improve data management for importers. For more information on how such platforms can assist, visit https://eudamedai.com/#funkcije.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.