A manufacturer located outside the Common Market (EEC, Switzerland, Turkey) placing medical devices on the Common Market, shall explicitly designate a single Authorised Representative within the area of the Common Market. The designation requires written form and must be accepted by the Representative in written.
For a single medical device or (generic) device group ONE Authorised Representative has to be designated.
The Authorised Representative shall be printed on the labelling and the instructions for use.
For manufacturers who are not established in the Common Market the Authorised Representative plays a pivotal role in the manufacturer's PMS-System ensuring the compliance of the medical devices and in serving as their contact person established in the Common Market. The tasks of an Authorised Representative shall be defined in a written mandate with the manufacturer which for example may allow the Representative to lodge an application for a conformity assessment procedure, to report events under the vigilance system or to register devices placed on the Common Market. The mandate should empower the authorised representative to duly fulfil certain defined tasks, including answering request for information about the product in due time.
Authorised representatives with the place of business in Austria are also obliged to register at the Austrian Medical Devices Register.
Created: 10.11.2014 | Page last modified: 25.01.2016