AR or EC Rep
All non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) on the European Community Market, CEpartner4U is your interface with the EU Competent Authorities.
CEpartner4U Authorized Representative services
- As mandated by the manufacturer (contact CEpartner4U for details)
- Manufacturer’s legal representation under the Medical Device Regulations and CEpartner4U’s name and address on product labels.
- Verification of the EC Declaration of Conformity
- Registration of devices as required under the Regulations, and the manufacturer’s mandate
- Responding to requests of Authorities
- Providing technical documentation to Competent Authorities, on their request
- Forwarding copies of all written requests, notifications and/or orders of the competent authorities and/or notified bodies and/or third parties to the extent they contain information related to the product(s)
- Informing the manufacturer about amendments to the Regulations
- Performing an annual surveillance review covering the status of the technical documentation.
- Submitting to the Competent Authorities manufacturer’s reports on incidents in accordance with the medical devices vigilance system.
- Informing the manufacturer about remedies in case of events that restrict the manufacturer with the free movement of his devices in the EU
- Arranging for Certificates of Free Sale
- Respond to ad hoc questions (fair use policy)
- The manufacturer has access to CEpartner4U templates and formats, supporting the Technical
Documentation and Quality Management System.
- Your documents, certificates and project related files are stored on a secure, ISO27001 certified datacenter, accessible only to personnel working on your project. Your data is never stored on laptops, desktop computers or portable media. We provide for remote access and up- and download of large amounts of data.
CEpartner4U holds in strictest confidence and never discloses, furnishes, communicates or makes accessible to any person or use in any way for CEpartner4U’s own or another’s benefit any confidential information.