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  • 1.  CE mark - EDQM Certificate of Suitability

    Posted 26-May-2014 07:06
    Hi all,

    Our device composed of collagen that purified from bovine tendon.
    Reviewer had requested us to provide EDQM Certificate of Suitability. Unfortunately, our supplier only have certificate for bovine skin instead of tendon. 

    Is there anyone know how to resolve this issue?
    Thanks!


    Loo



  • 2.  RE: CE mark - EDQM Certificate of Suitability

    Posted 27-May-2014 08:41
    Mr. Tung
        Please see the EU guidance on animal sourced materials (virtually the same as the US FDA guidance). If the supplier cannot certify compliance with the requirements (there can be several possible reasons - starting with where is the supplier located? ) for the collagen that you are proposing to use, the most direct response is to either have them validate their processes for this material (showing aggregate 4 order of magnitude reduction in test virus loads by the process, or testing lots to show an absence of viruses - a surrogate, as the real primary concern is prions, for which there is no recognized quantitative assays) or for you to get same. Place to statr, however, is to please review the guidance and idenify the sourcing of animals used.

    Best of luck  

    -------------------------------------------
    Shayne Cox Gad ScD PhD
    Principal
    Gad Consulting Services
    Cary NC
    United States
    -------------------------------------------






    Original Message


  • 3.  RE: CE mark - EDQM Certificate of Suitability

    Posted 27-May-2014 20:19
    Dear Loo,

    You need to put a Technical File together by using the data available, and CE mark it.
    If there is none, you can not sell the product.

    http://www.edqm.eu/en/certificates-of-suitability-products-97.html
    Review the link above.

    Normally, there is a supplier qualification for raw materials that includes a selection of certified products.
    Good luck.

    -------------------------------------------
    Lena Huerlimann RAC
    Lead Medical Device Auditor
    Redmond WA
    United States
    -------------------------------------------






    Original Message


  • 4.  RE: CE mark - EDQM Certificate of Suitability

    Posted 28-May-2014 16:29
    Hi Loo,

    I see two possible resolutions:

    1) Ask the supplier to obtain an EDQM certificate for the tendon collagen. This can take several months, but since they already have one certificate, they know the process and will probably have the documentation readily available. Your reviewer may accept this as a non-conformance and give you time to get the certificate, particularly if the supplier uses equivalent procedures for inactivating viruses.

    2) Switch suppliers. EDQM maintains a database of TSE certificates (search collagen, TSE only)
    https://extranet.edqm.eu/publications/recherches_CEP.shtml But this puts the onus back on your company to demonstrate that your product is equivalent.

    Also note that if you are thinking of marketing your product in the US, FDA issued a guidance in January 2014 requiring a 6 log clearance in viral inactivation studies
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm381379.htm#s4c

    Best of luck!
    Karen

    -------------------------------------------
    Karen Long
    Richmond BC
    Canada
    -------------------------------------------






    Original Message


  • 5.  RE: CE mark - EDQM Certificate of Suitability

    Posted 29-May-2014 01:43
    Hi Shayne, Lena, and Karen,

    Thank you so much for providing the solutions.
    I really appreciate it!

    Good day to everyone!


    Loo 






    Original Message