EU Authorized Representative service
Your pathway to the European Union
medical device market
The EU MDR (2017/745) and and EU IVDR (2017/746) state that, regardless of the device class, to place a device into the EU market, a manufacturer established outside the EU, is required to have an EU Authorized Representative. The representative must be located within the European Union and is designated with a mandate.
EU Authorized Representative service by MDBS
Fineltec's Medical Device Business Solutions (MDBS) offers EU Authorized Representative service for non-EU medical device manufacturers, who want to access the European market.
MDBS will guide you through the process of EU Authorized Representative designation. Once the service is up and running, MDBS will carry out all the EU Authorized Representative duties for you as required in EU MDR (2017/745) and EU IVDR (2017/746).
EU MDR (2017/745) and EU IVDR (2017/746) require that the EU Authorized Representative designation is made in the form of a mandate. This mandate is to be understood as a power of attorney by which the manufacturer gives another legal entity the authority to perform specific tasks for them.
- Shall be done in writing
- Shall be accepted by both parties
- Shall provide a sole authorized representative for a device
- Shall cover all devices of the same device group
- Shall specify the list of authorized representative tasks
- Shall not delegate any of the manufacturer’s obligations to the authorised representative
Conditions for the Designation
EU MDR (2017/745) and EU IVDR (2017/746) set number of conditions for the Manufacturer and for the EU Authorized Representative.
In summary, for all device classes, the Manufacturer must
- Be established outside the EU
- Have a drawn-up EU Declaration of Conformity
- Have compiled technical documentation
- Have a quality management system
Whereas the EU Authorized Representative must
- Be established within the EU
- Have a person responsible for regulatory compliance (PRRC) permanently and continuously at disposal
- Ensure that the PRRC possesses the requisite expertise
EU Authorized Representative
- Designated EU Authorised Representative
- EUDAMED Registrations
- Single Registration Number (SRN)
- Competent Authority Liaison
- EU Mailbox and Address
Our mission is to provide high quality services with a personal touch. We cooperate closely with our customers, helping them to grow together with a reliable partner. We understand our customers’ needs and assist them to be one step ahead on the fast-moving market.
- Established in 1993
- Nearly 100 employees
- Production facility of 4000 m2
- 17 million Euro turnover
- EU location