Updated version of the EU “Blue Guide” published!

On the 5th April 2016, the European Commission published an updated version of “The Blue Guide on the Implementation of EU Product Rules”. The document, commonly referred to as the “Blue Guide [...]

European Commission Publishes New Guidelines on PPE Directive

On 19 October 2015, the European Commission published new Guidelines on the application of Personal Protective Equipment Directive 89/686/EEC (PPE Directive). (more…) [...]

Common Approach on the Medical Devices Legislative Package

On October 5, 2015, the Ministers of the EU countries agreed, after almost three years of discussions, on a general approach on the medical devices legislative package. This agreement is a major step [...]

Final Opinion on the Safety of Medical Devices containing DEHP (phthalate)

After months of public consultation, The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has now published the final Opinion on the safety of medical devices containing DE [...]

Authorised Representative

What is an European Authorised Representative (E.A.R.)?

An Authorised Representative is any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive.

What are the Role and Duties of a E.A.R.?

The role and duty of an European Authorised Representative include, but are not limited to:

  • Provide a registered address in the European Union
  • Keep available the Technical Documentation for inspection by the European Authorities.
  • Complete Notification to the European Authorities
  • Complete (any) registration to National Databases
  • Take care of (any) incident reporting
  • Represent the manufacturer towards the Commission, Authorities and Notified Bodies.
  • Safeguard compliance with constant regulatory updates.
  • Consult on European Regulations.   

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