EU AUTHORISED REPRESENTATIVE
With the entry into force of the new Regulation (EU) 2017/746 of the European Parliament, it necessary to have an authorised Representative in the EU. 300K Solutions can be your partner since we are accredited to be an authorized representative in the EU.
What can we do for you?
Assist with Field Safety Corrective Actions and inform the manufacturer about suspected incidents related to the devices.
Keep available a copy on the Technical Documentation and Declaration of Conformity or Certificate of Conformity.
Assist with MD and IVD registration obligations.
Provide all the information and documentation required when requested by the Competent Authority.
Service as European Authorized Representative for Medical Devices (MD) and In-Vitro Diagnostic Medical Devices (IVD).
Consulting on regulatory requirements for commercializing MD and IVD in the European Union.
Our team of professionals is ready to listen and assist you