Authorised Representative

An Authorised Representative is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their  behalf. This person may be addressed by authorities and bodies within  the Community, instead of the manufacturer themselves, with regards to  the requirements of this Directive.

What are the duties of an E.A.R?

The  role of a European Authorised Representative is both varied and  challenging. The main duties include, but are not limited to, the  following:

• Providing a registered address within the European Union
• Keeping all technical documentation available for inspection by the European Authorities
• Completing notifications to European Authorities
• Completing any registrations to national databases
• Taking care of any incident reporting
• Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
• Safeguarding and ensuring compliance with constant regulatory updates
• Consulting on European Regulations

Learn More:

• Scope
• Classification
• The Directive: MDD 93/42/EEC
• Technical File
• Notified Body under the MDD
• Custom Made Medical Devices
• Clinical Investigation
• Kits
• Risks of Non-Compliance

Non-EU  based manufacturers are obligated to appoint a European Authorised  Representative to serve as their vigilance contact point and ensure  continued compliance at all times.