When a medical device manufacturer is established outside of European Union, the manufacturer needs to appoint an eu 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 Union Community who can act on behalf of the manufacturer.
A written mandate/letter designating an eu authorised representative for a medical device manufacturer is mandatory. The EU authorised representative must provide a copy of the mandate to the competent authority when requested.
Different Tasks performed by European Union
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 union regulations.
- To terminate the mandate if the manufacturer acts contrary to its obligations under this European 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]