What is an Authorised Representative for medical devices?
Essentially, an Authorised Representative (AR) plays an intrinsic part in post-market surveillance, including vigilance. The AR is your link to European authorities, and they must maintain physical presence in Europe. They will register your medical device or IVD before it is marketed, and will always be available to serve as a contact between you and the Competent Authorities of the EU member states. Your AR will also have access to your Technical File(s), which must be available for inspection by the Competent Authorities. In other words, a variety of the responsibilities of the manufacturer are delegated to the Authorised Representative. The name, address, and telephone number of your AR must be placed on the information that accompanies your device, such as (packaging) labeling and instructions for use. In the event of an incident, your AR will assist and coordinate the reporting of the incident to the Competent Authorities, and will cooperate with you and your distributors to ensu
