Authorized Representatives
Articles 11 of the MDR and IVDR outline the essential functions and responsibilities of Authorized Representatives.
Authorized Representatives act as a bridge between non-EU manufacturers and EU regulatory authorities. They are appointed by manufacturers based outside the EU to carry out specific tasks on their behalf. Authorized Representatives must register themselves and the devices they represent in the European Database on Medical Devices (EUDAMED). This registration provides visibility to competent authorities.
ARs serve as the primary contact point with EU Competent Authorities. They ensure that the manufacturer's technical documentation and conformity assessment procedures are available for scrutiny. ARs review the labeling and instructions for use to ensure they comply with EU requirements. They also play a role in validating that the device is appropriately marked with the EU Authorized Representative's name and address.
ARs are responsible for forwarding information on incidents and corrective actions to the manufacturer. They also assist in the coordination of necessary actions within the EU.
While ARs have specific responsibilities, they usually do not assume the legal liability for the device. The manufacturer remains ultimately responsible for the compliance and safety of the device.
Authorized Representatives are required to keep technical documentation, declarations of conformity, and other relevant documents for each device they represent for a period of at least 10 years.
Importers
The functions of importers within the European Union are delineated in Articles 13 of both MDR and IVDR.
Importers are entities responsible for placing medical devices from non-EU countries on the EU market. Importers can be manufacturers themselves or distinct entities involved in the supply chain.
Importers must ensure that the devices they import comply with the requirements of the MDR or IVDR. This includes verifying that the manufacturer has carried out the necessary conformity assessment procedures.
Like ARs, Importers must register themselves and the devices they import in EUDAMED. This registration helps in monitoring the devices in the market. Besides, similar to ARs, importers are responsible for forwarding information on incidents and corrective actions to the manufacturer and cooperating with competent authorities.
Importers are required to keep a copy of the EU declaration of conformity, the instructions for use, and information on the origin and traceability of devices for a period of at least 10 years.
Importers share legal liability with the manufacturer for ensuring that the devices they place on the market comply with EU regulations. They are considered economic operators and must fulfill their regulatory obligations. They are expected to actively contribute to market surveillance by cooperating with competent authorities, providing them with any information they may need, and, when required, ensuring the withdrawal or recall of non-compliant devices.
