European Authorised Representatives

It is a legal requirement that any company outside of the EU wishing to place a medical device on the market within the European Community must appoint an Authorised European Representative

The Representative undertakes the responsibility to represent the off -shore company with regard to all regulatory and legal aspects related to the medical device.

The Representative has the responsibility to:

• register the off-shore company with the European Competent Authority
• register each product group of medical devices with the European Competent Authority
• provide the European Competent Authority the name, address and telephone number of the Representative’s trading address

Responsibilities also include reporting to the EU Notified Body & Competent Authorities:

• any change to the design of the device
• changes to manufacturing processes
• all incidents or near incidents related to the medical device

• issuing advisory notices as & when appropriate
• issuing product recall notices & when appropriate

The Authorised Representative also reports to the off-shore company:

• ongoing regulatory requirements and amendments
• changes to EU regulations & legal requirements
• details of complaints relating to the product
• details of incidents/near incidents relating to the product
• monitors and reports on new developments in European product legislation relevant to your products
• full supporting information

We assure full product and technical information confidentiality at all times

The above services are provided for an annual pre-determined fee based upon the type, class and number of product groups placed on the EU market regardless of sales volume, there are no hidden extras

There is a modest initial set up charge to cover Competent Authority registration fees and administrative requirements