Under the current legislation, the Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the EU.

MEDITRIAL IS A CERTIFIED EUROPEAN REPRESENTATIVE SERVICES FOR THE SUCCESSFUL MARKETING OF YOUR MEDICAL DEVICES IN EUROPE

WE REPRESENT APPROXIMATELY 100 COMPANIES

TASKS OF THE AUTHORIZED REPRESENTATIVE UNDER THE MDR:

To verify:
the drafting of the EU declaration of conformity;
technical documentation by the manufacturer;
the carrying out of the conformity assessment procedure by the manufacturer;
To keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate at the disposal of competent authorities for the period referred to in Article 10(8) of the new MDR;
Take care of (any) incident reporting;
To comply with the registration obligations laid down in Article 31 and to verify the manufacturer compliance with the registration obligations laid down in Articles 27 and 29;
To provide competent authority with all the information and documentation requested by it and necessary to demonstrate the conformity of a device;

Why choose Meditrial as your European Authorized Representative?

Using our specialized expertise in complex European medical device legislation, Meditrial provides fast study notifications and product registrations for medical devices within the EU.

Our experts our experts are highly skilled to manage incident reporting and assist in the preparation of Declarations of Conformity and the application of various other Certificates.

ACCORDING TO THE MDR AND IVDR THE EU AUTHORISED REPRESENTATIVE BECOMES FULLY RESPONSIBLE FOR THE MANUFACTURER’S DEVICES.
THE MDR HAS BEEN POSTPONED TO MAY 2021, WE ENCOURAGE YOU TO START WORKING ON THE REQUIRED DOCUMENTATION.

TAKE ADVANTAGE OF THIS TIME TO MANAGE THE TRANSITION PROCESS VERY EFFICIENTLY NOW

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