European Authorized Representative Sevices

Is it compulsory for a non-EU medical device manufacturer to appoint a European Authorized Representative (EAR)?

As of March 2010, a Single EU European Authorized Representative (EAR) shall be designated by a non-EU manufacturer of medical devices, as this required by Article 14.2 of the Council Directive 93/42/EEC.  The EAR shall be established (have a registered business) within the EU and shall act on manufacturer’s behalf, for specific designated tasks.

Our services

Our EAR Department can assist you with:

  • Dealing with the Regulatory Authorities.
  • Keeping, for a period extending to at least five (5) years after manufacture of the product, the Technical File available for review and inspection by EU Enforcement and/or Surveillance Authorities. If such Authorities make a request, we will shortly inform you of this request and will then give access to your Technical File information.
  • Provision of Registering, Updating and Notifying services of class I, IVD (In Vitro Diagnostic) and Medical Devices to the EEA Enforcement Authorities.
  • Providing assistance in Vigilance/Incident Reporting, in Product Recalls and in the issuance of Advisory Notices.

Benefits in designating Cert.Pros as your EAR

  • Signing a legally binding document between the manufacturer and Cert.Pros as EAR is the first step. This legal document is actually a written agreement, which clearly lists and identifies the main duties and responsibilities of both involved parties. 
  • After signing the agreement, the manufacturer issues all required documentation, as this is imposed by our relevant checklist. 
  • Our EAR department carries out medical product registration according to the relevant Directive requirements so that the product can be freely placed on the European market. 
  • Upon request, Certificates of Registration can also be issued 

For further information regarding our EAR services, please contact us at This email address is being protected from spambots. You need JavaScript enabled to view it. and a member of our EAR team will be with you shortly. 

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Our Location

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Our Head offices are located in Covent Garden, London, UK. 

 

Cert.Pros team comprises more than a hundred certification experts throughout Europe and Asia.