Manufacturers who are not established in any EU member state must designate a natural or legal person to be responsible for placing their devices on the EU market. This authorised representative's name and address are to be shown on the label or the outer packaging or instructions for the use of the device.

The responsibilities of the authorised representative include:

• registration of the manufacturer
• registration of the device(s)
• filing and making available technical documentation of the medical device(s) to the competent authorities of all EU member states and to the Notified Body upon request
• coordinating the incident handling and reporting between the persons involved, the European authorities, the Notified Body and the manufacturer
• organising and supervising product recalls

These responsibilities require a comprehensive understanding of the European medical device regulatory system, ability in medical and technical assessment, as well as in communication with the authorities in all EU member states.

Im most cases, distributors are focused on one or a few markets and have limited regulatory experience. Therefore, in our experience, they are not suitable to act as authorised representatives of medical device manufacturers.

For that reason, we recommend persons and organisations specialising in European Regulatory Affairs to take on this role (see http://www.eaarmed.org/).