Authorised representative mandate under Article 11 of the MDR or IVDR
Registration of the mandate in EUDAMED
Verification of your EU declaration of conformity and technical documentation
A copy of your technical documentation kept permanently available for competent authorities
Acting as your contact point for competent authorities in the EU
Forwarding of information requests, with acknowledgement within one business day
Notification of regulatory changes affecting your registered devices
Representation for the Turkish market under the same mandate