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  • 1.  EUDAMED Tradenames

    This message was posted by a user wishing to remain anonymous
    Posted 15-Apr-2024 16:45
    This message was posted by a user wishing to remain anonymous

    Hello,

    We have had some discourse with our EU AR for the last few weeks on allowance of a tradename/dba on our EUDAMED account. For example, our legal name is Company A LLC, but we have our marketing/tradename/dba as Company B. Our CE certificates reflect "Company A LLC dba Company B". The Dutch Competent Authority has declined our EUDAMED update and states that according to MDR Annex XII, the single manufacturer statement means no dba allowed. Has anyone else had this pushback? Throughout the MDR tradename is mentioned for labeling etc., but this one line in Annex XII is not allowing the rest of the tradename allowance to happen as "everything must match". 

    Exact message from Dutch CA: 

    The Ministry of Health, Welfare and Sport received from the administrator of Eudamed a file with manufacturers, validated by the CIBG.

    In the file the manufacturers have either « doing business as » (dba) or « trading as » in their name.

    The CA interpret MDR Annex XII as: only 1 manufacturer/SRN on the certificate, which implies that there can only be 1 trade name on the certificate.

    A correction in the name is required, « doing business as » (dba) or « trading as » in their name is not allowed.

    Can you please contact the actor, asking to correct their name in EUDAMED and obtain an SRN/Actor ID for each different manufacturer where necessary?



  • 2.  RE: EUDAMED Tradenames

    Posted 15-Apr-2024 17:46
    Edited by Kevin Randall 15-Apr-2024 17:48

    We'll need more details to answer definitively.  But is it really your EC certificates that currently show both names? Or instead, is it your Declarations of Conformity? If the former, then it means the Notified Body did not disagree with (though perhaps should have) the two names.  The Notified Body is supposed to be more reflective of the Competent Authority, so a misalignment there could be a concern and require even further painful resolutions.  My experience is that the ARs are not always properly or fully versed on such matters, so their interpretation would be less authoritative.

    Ultimately, the Competent Authorities [a.k.a., market surveillance authorities in the spirit of market surveillance Regulation (EU) 2019/1020 which doesn't directly apply regarding EUDAMED and regulation 2017/745 devices, but the principles of which are still intact for medical devices] need to be able to definitively and quickly identify the manufacturer economic operator. Where multiple names are present in EUDAMED, additional clarifiers are needed since "d.b.a." may not be universally recognized in meaning and has no corresponding EN ISO 15223-1 symbol and so thus it is not 100% clear to the Dutch market surveillance authority.

    I'm hoping your device label states only Company B with no mention of d.b.a.  In that case, why not just use the Company B name in EUDAMED and call it good so as to avoid further complications (such as if the NB and CA are not in alignment). It would be unfortunate if you wind up having to revise your entire technical documentation, Declarations of Conformity, EC Certificates, AND the EUDAMED entry...



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 3.  RE: EUDAMED Tradenames

    Posted 16-Apr-2024 09:30

    Our EC certificates (and DoCs in reflection) have our legal name plus the tradename/dba. We are actually going through a re-branding to a new tradename to complicate things even further. Our labels currently state a "Company C" and we are wanting to change everything to "Company B", no dba on customer facing documents.



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    Alena Newgren
    Regulatory Affairs Manager
    United States
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  • 4.  RE: EUDAMED Tradenames

    Posted 16-Apr-2024 02:35

    This is about linking a legal person to a name. That should be clear and unambiguous. I suggest you to start building the case from there: who is the legal person and this entity must be registered in EUDAMED. Next, you may be able to link trade names to that person. However, this means that anything done under that trade name will reflect on the legal person who registered it. 

    Reach out if you need help with this.



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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