When a medical device manufacturer is established outside of European Union, the manufacturer needs to appoint an authorised representative to place a medical device in one of the member states. An Authorized Representative is any person naturally or legally established in the European Community who can act on behalf of the manufacturer.
A written mandate/letter designating an authorised representative for a medical device manufacturer is mandatory. The authorised representative must provide a copy of the mandate to the competent authority when requested.
The authorised representative shall perform the following tasks specified in the agreement between it and the manufacturer.
- To represent the manufacturer towards the European Commission, Authorities and Notified Bodies.
- To verify that the EU declaration of conformity and technical documentation of the device is up to date and appropriate conformity assessment has been carried out by the manufacturer.
- To keep available a copy of the technical documentation, the EU declaration of conformity and a copy of the relevant certificate for inspection by European Competent Authority.
- To register a device with the national databases before they are marketed.
- To provide necessary information and documentation to demonstrate conformity of the device in response to a request from a competent authority in an official Union language determined by the Member State concerned.
- To forward to the manufacturer any request by a competent authority of the Member State for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device.
- To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- To immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device.
- To ensure the device is compliant with updated regulations and advise manufacturers on updates of European regulations.
- To terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
How we assist you with this process?
- Act as your EU Authorised Representative
- EUDAMED registration
- Local country registrations
Why Choose Us
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Contact us for free consultation: [email protected]