Regulatory Open Forum

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  • 1.  CE Mark

    Posted 07-Jun-2012 09:12
    Is it possible for a CE Mark certificate to reflect two names, i.e., the name of the corporate entity and also the name of the manufacturing facility.  In this case, the manufacturing facility is a wholly-owned subsidiary of the corporate entity.

    Thanks for your help!

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    Theresa Marascio
    Regulatory Affairs Manager
    US-HIFU
    Charlotte NC
    United States
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  • 2.  RE:CE Mark

    Posted 08-Jun-2012 02:47
    Must show the name of the "manufacturer", i.e. whoever is legally responsible for placing the product in the market. The owner will be the manufacturer, who will be subcontracting his subsidiary or any other subcontractor (through a quality agreement or other type of contract binding). In case the owner OWNS several facilities (owns, NOT the facilities owned by its subsidiaries), then may be the CE certificate will state the facilities audited (imagine the case where company A owns factories X, Y and Z, all producing the same product, but only X has been audited hence certified).

    In case the subcontractor is not ISO13485 certified, then the notified body may have to audit the subcontractor as well.

    Hope this helps a bit...

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    Alexis Hadjiioannou
    Athens
    Greece
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    Original Message


  • 3.  RE:CE Mark

    Posted 08-Jun-2012 10:35
    Theresa,

    The Declaration of Conformity must contain information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union. If the manufacturer's is a wholly-owned subsidiary and legally registered and known as such it would be included as the name of the facility. The key is to list the name of the manufacturer. 

    Hope this helps!

    Dar


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    Darlene Rosario
    VP Research Program Management, Oncology
    Oxnard CA
    United States
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    Original Message


  • 4.  RE:CE Mark

    Posted 08-Jun-2012 23:49


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    J Council
    United States
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    Hi Theresa:  

    The certificate must describe the name of the" manufacturer." (see insert from the council directive below).  In your case, in  the event the corporate and manufacturer have different addresses, this will cause confusion.  Also, it was the manufacturer that affixed the CE marking, not the corporate office.  BTW, check your Technical construction file or dossier and ensure the names and addresses are in sync. Of course, if corporate is the identical manufacturer and has the identical address, you should consult with your NB or AR.

    "...The certificate must contain the name and address of the manufacturer..."

    Best wishes and hope this helps!

    Jerome Council
    Quality Systems and Regulatory Compliance Specialist
    Georgia, USA



    Original Message