J
I like to put a question to this forum. The question is about the responsibilities of the EU Authorized Respresentative (AR) for medical products (lifts and beds) Class I and IIa in EU. I will probably get this task shortly. Representing manufacturers from US, Mexico and Signapore.
I have read MEDDEV 2.5/10, which states:
To my opion this is not inline with the current role of the AR:
For new or modified products the AR does a Regulatory Affaires Assessement (RAA) , per EU country, searching for applicable standards (flammability, specific product regulation, etc). After completing this RAA these requirements are sent back to the Manufacturer for development.
In this case the AR determines the technical requirements of the end product, is this correct? What should you propose how to handle in this case? The new AR contract is not yet drafted.
Please let me know.
Regards
John
I have read MEDDEV 2.5/10, which states:
The manufacturer is responsible for his obligations under the Medical Device
Directives, not the authorised representative.To my opion this is not inline with the current role of the AR:
For new or modified products the AR does a Regulatory Affaires Assessement (RAA) , per EU country, searching for applicable standards (flammability, specific product regulation, etc). After completing this RAA these requirements are sent back to the Manufacturer for development.
In this case the AR determines the technical requirements of the end product, is this correct? What should you propose how to handle in this case? The new AR contract is not yet drafted.
Please let me know.
Regards
John