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 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