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  • 1.  CER- Demonstration of Equivalence- Access to TF

    This message was posted by a user wishing to remain anonymous
    Posted 13-Mar-2017 16:16
    This message was posted by a user wishing to remain anonymous

    Greetings!

    In terms of demonstration of equivalence, is it required to have the access to other manufacturer's technical file of the equivalent devices?
    As per the MEDDEV guidance document- 2.7/1, rev.4,
    "Demonstration of equivalence might be difficult or impossible in case of limited access to the technical documentation of the devices."

    Many medical device companies state they cannot establish equivalency without access to other manufacturer’s technical files, which is difficult especially if the manufacturer does not hold the TF. Therefore, I would like to get an opinion on this particular concept from a Notified Body perspective. Looking for some feedback, any input would be appreciated!



  • 2.  RE: CER- Demonstration of Equivalence- Access to TF

    Posted 14-Mar-2017 09:23
    We have asked this exact question of our Notified Body.  The answer received was more settling (for us anyway) than the original thought that we MUST have an agreement with the equivalent device manufacturer.  If you can demonstrate equivalence from data gathered through public means or otherwise, then there is no need for a Tech File agreement with the equivalent device manufacturer.  Therefore, we make sure we state this exact statement in our CERs, just in case we are challenged by our Notified Body at our next audit.  
    Disclaimer: We have yet to be audited to MEDDEV 2.2/1 Rev 4, so only time will tell if the auditors challenge our equivalence demonstration.
    Hope this helps!

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    Rene' Hardee
    Regulatory Affairs Specialist III
    Sun Nuclear Corporation
    Melbourne FL
    United States
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    Original Message


  • 3.  RE: CER- Demonstration of Equivalence- Access to TF

    Posted 15-Mar-2017 07:13
    My approach would be to use a 510(k) Substantial Equivalence analysis as a section in your Technical File and where relevant do head to head performance testing if possible using the same methodology. Perhaps, as in my last company, your device is subject to an ISO standard, i.e., for dental cements. 

    Test both, and if similar or both meet the standard, have same intended and indications for use, same basic technology (eugenol based cement).....similar delivery mechanism, they are SE.

    STED dossiers also require discussion of substantial equivalence, and this approach has worked for me there, as well as with Notified Bodies, without access to a competitor's technical data.

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    715-307-1850



    Original Message


  • 4.  RE: CER- Demonstration of Equivalence- Access to TF

    Posted 14-Mar-2017 10:52
     
    Hello,
     
    The short answer to your question is yes, the manufacturer will need access to the technical file for the other device.  The notified body must evaluate the level of access to the technical and clinical data for the other device to which the manufacturer has access, realizing that some if not much of the data required will be confidential.  Special manufacturing processes, certain material characteristics, etc. are generally confidential, for example.  Without access to the technical data for the equivalent device, the manufacturer will struggle to provide a justification for equivalence that will meet the notified body expectations. 
     
    I hope this helps.

    Carol
     






    Original Message


  • 5.  RE: CER- Demonstration of Equivalence- Access to TF

    This message was posted by a user wishing to remain anonymous
    Posted 21-Mar-2017 09:01
    This message was posted by a user wishing to remain anonymous

    Thank you everyone for the valuable inputs. This will be help us in our future CERs.
    Original Message


  • 6.  RE: CER- Demonstration of Equivalence- Access to TF

    Posted 24-Mar-2017 02:16

    Dear Colleagues,

    Personally, I believe, that in case a product complies with the applicable regulations and standards, additionally its key clinical performance indicators are identical with the ones of a device selected for equivalency analysis, they may be regarded equivalent. E.g. in case of monofocal intraocular lenses,      if the principle of operations of two products are identical (monofocal optical lenses), the optical performance is according to the relevant standard (ISO 11979-2), the geometry is very similar, the  materials are acrylic, the UV filters are equally effective and the haptic forces are within the range safe for the lens capsule, these products are clinically equivalent.

    I think that in most of the cases with the use of well-reasoned and fairly selected clinical performance indicators, equivalency of performance and risk/benefit can be fairly justified. Good bench testing is necessary, limited comparative clinical studies might be needed.

    This is the way, how generic medicines are approved as well.

    I believe, that this is in lien with the interest of the health care funds. Taking the equivalency very hard the price of the “generic” products would be unacceptably high for consumers.



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    Peter Miko
    Gyermely
    Hungary
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    Original Message


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