MedQ Consultants B.V. will continue to provide EU Authorized Representative services under the Medical Device Regulation (EU) 2017/745 (MDR).
When the MDR was released, it became clear that the regulation adds more stringent obligations to manufacturers and authorized representatives. The obligations of authorized representatives are described in MDR Article 11.
An EU authorized representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the MDR.
Where many companies have stopped offering EU authorized representative services under the MDR, MedQ Consultants B.V. decided to continue offering EU authorized representative services under the MDR in collaboration with sister company MedR-AR Services B.V. The knowledge and expertise of MedQ Consultants B.V. combined with the stability and knowhow of MedR-AR Services B.V. is the ideal combination to successfully provide manufacturers with their needs in regard to EU authorized representative services under the MDR.
For more information regarding the MDR EU authorized representative changes as well as our services, please contact one of our specialists via info@medr.eu.