Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), an importer is defined as any natural or legal person established within the European Union who places a medical device from a third country onto the EU market. The key criteria for an importer, as specified in the regulations, are:
- The importer must be established within the EU.
- They are directly responsible for ensuring that devices originating from outside the EU comply with the regulatory requirements before being placed on the EU market.
Obligations of Importers
The obligations of importers are clearly defined in Article 13 of the MDR/IVDR. These obligations can be summarized as follows:
- Compliance Verification: Importers must ensure devices are CE marked, have an EU Declaration of Conformity, and meet all MDR requirements before placing them on the EU market. This includes verifying manufacturer identification, an authorized representative, appropriate labelling, instructions for use, and UDI assignment (if applicable).
- Non-Conforming Devices: If a device does not comply with MDR or poses serious risks, importers must prevent its placement on the market, notify the manufacturer, authorized representative, and competent authorities, and assist with corrective actions.
- Importer Identification: Importers must display their name, address, and contact details on the device, its packaging, or accompanying documents without obscuring the manufacturer’s information.
- Device Registration: Importers must ensure devices are registered in the MDR electronic system and add their own details to the registration.
- Storage and Transport: Importers must ensure that storage and transport conditions preserve the device’s compliance with safety and performance requirements and adhere to manufacturer guidelines.
- Complaint Handling: Importers must maintain a register of complaints, non-conformities, recalls, and withdrawals, sharing information with manufacturers, authorized representatives, and distributors to support investigations.
- Incident Reporting: Any complaints or incident reports from healthcare professionals, users, or patients must be forwarded to the manufacturer and its authorized representative.
- Document Retention: Importers must retain copies of the EU Declaration of Conformity and any relevant certificates for the required period under MDR.
- Cooperation with Authorities: Importers must collaborate with competent authorities to address risks, provide samples, or grant access to devices when requested.
These obligations ensure that importers play a crucial role in maintaining compliance and ensuring the safety and effectiveness of medical devices on the EU market.
Importers and Regulatory Compliance
While appointing an importer is not mandatory under MDR/IVDR, the obligations assigned to importers are mandatory. If no importer is designated, these responsibilities default to the distributor (please refer to question 3 of MDCG 2021-27 Rev.1). However, distributors may find these extensive obligations beyond their expertise. Additionally, even if you do have an importer assigned, some importers may prefer to focus solely on the physical logistics of importing devices and may not wish to manage the regulatory checks and responsibilities.
Advena’s Regulatory Importer Services
This is where a service like Advena’s Regulatory Importer Solution becomes invaluable. Advena offers a comprehensive service that removes the regulatory burden from importers while maintaining compliance. Key benefits of this service include:
- Remote Verification: Advena verifies all shipment-related documentation remotely, eliminating the need for physical inspections.
- Supply Chain Integrity: Manufacturers can continue using their existing supply chain and logistical routes without disruption.
- Regulatory Assurance: Advena ensures that the importer’s regulatory obligations are fulfilled, allowing manufacturers to focus on their core operations.
Please feel free to contact us at: info@advena.mt should you want a quote for our importer service.
