Hello Anon,
Indeed that might be interesting, but I think most companies have their own standard template for Declaration of Conformity (DofC). In addition, if the DofC is structured correctly, the amount of translation would be minimal. I do really like the idea, because the "standard" sections would be the same: Manufacturer, Authorised Representative, Product Name, Product Model, etc., there is definitely an advantage of only having one version of DofC that exists ... hint hint EU Commission :). It might also be in the future once EUDAMED is fully functional this might be a mute point as well if everything is uploaded electronically or entered into a website portal.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 24-May-2021 07:40
From: Anonymous Member
Subject: Declaration of Conformity template - EU MDR all languages
This message was posted by a user wishing to remain anonymous
Dear all,
it would be interesting to work together at a DoC template compliant with EU MDR and translated in all applicable languages.
What do you think about?