Eudamed actor registrations if you change AR for MDR product

A

Awadine

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#1
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Hi

Hoping for some advice so I can get actor registrations correctly completed in Eudamed before we start registering devices.

We are a non-EU manufacturer currently using Authorised Rep A for Legacy MDD product placed on the EU market. When we transition to MDR certification, we will be using Authorised Rep B for our MDR device portfolio. But we are likely to continue to place MDD product on the EU market under AR A for several years after we get MDR certification.

How do we set this up correctly in the Eudamed actor module so legacy product can be assigned to AR A and MDR product can be assigned to AR B?

Each manufacturer entity can only assign 1 AR entity in Eudamed. Is there a simple way to address this that I am missing?

Many thanks.
 
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