Regulatory Open Forum

 View Only

  • 1.  Legacy device DOC when company changes its legal name

    This message was posted by a user wishing to remain anonymous
    Posted 26 days ago
    This message was posted by a user wishing to remain anonymous

    Hi all,

    What happens when a non-EU manufacturer of a legacy device changes ownership and changes its legal name (becomes a different entity)?

    If the "new" company is taking no new instruments to the EU market, can business continue as usual?

    Can a new Declaration of conformity be issued with the new company name?



  • 2.  RE: Legacy device DOC when company changes its legal name

    Posted 25 days ago

    Anon,

    The scenario being presented is a little confusing, because if the "new" company is not placing products in the EU market, why would there even be a need for a Declaration of Conformity (DofC).  If you are meaning there is an existing product being sold in the EU and Company A bought this product from Company B; and Company A are going to continue selling the same product in the EU.  And Company A does not currently sell in the EU nor plan to sell any other products in the EU.

    It highly depends on the classification of the device and if there is Notified Body intervention.  If the product is Class I with no Notified Body intervention, then yes, the DofC can simply be updated with the name of the new company.  There are of course administrative information which needs to be done behind all of this including notifications to an Authorised Representative and potentially updates to individual country registrations (if applicable).  If the product requires Notified Body intervention, then there is a lot more which needs to happen beyond just updating the DofC with the new company name.  This may require notification to the Notified Body, potentially QMS review if something is changing or moving, and of course more administrative activities when there is a Notified Body involved.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------

    Original Message


  • 3.  RE: Legacy device DOC when company changes its legal name

    This message was posted by a user wishing to remain anonymous
    Posted 25 days ago
    This message was posted by a user wishing to remain anonymous

    Hi Anon

    If it's essentially the same entity, you can append a signed page to the legacy DoC telling the name change.


    Original Message


  • 4.  RE: Legacy device DOC when company changes its legal name

    Posted 25 days ago

    Hi Anon,

    difficult to say exactly without more details, so some general remarks:

    Assuming you have a situation as describen in MDCG 2020-3 rev.1, section 4.2 then:

    "changes of the manufacturer's name, address or legal form, including a merger or acquisition involving the manufacturer" are not considered significant changes (with the additional remark that "(t)his does apply only in cases where the legal entity certified under the directive(s) continues to exist. Not covered are situations where the manufacturer certified under the directive(s) will transfer device(s) covered by those directive certificate(s) to another manufacturer who will place these device(s) on the market under the MDR."

    So in principle you can keep placing the respective legacy devices (with adapted labelling) on the market as long as there is no additional change (which I assume is what you mean by "taking no new instruments to the EU market") - business could continue as usual.

    If you have a certificate for the legacy device then you will need to notify the change (before you start placing devices on the market under the new name) to your NB and they will probably issue an amendment to the existing certificate (they cannot issue a new certificate). I have not yet seen this done for a name change, but for a change in address this worked. In case of an up-classified class I device without a certificate this step does not apply to you.

    With respect to the Declaration of Conformity the usual solution I have seen (again with address change rather than name change) would be to again leave the "original" DoC as it is and issue an amendment explaining the new situation. The competent authorities I have talked to about this would not allow you to issue a completely new DoC (in the case of up-classified class I devices, the legacy device status depends on the availablity of an "old" DoC, so you will need to keep this available anyway).

    However, details matter so this might not apply to your specific situation and it would be important to do an analysis with all the details known.

    Best regards, Christoph



    ------------------------------
    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
    ------------------------------

    Original Message


Related Content