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Additional Notified Body

Discussion in 'EU Medical Device Regulations' started by Jo Campbell, Oct 15, 2015.

  1. Jo Campbell

    Jo Campbell Member

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    Hi All,

    We are certified to ISO 13485 and ISO 9001, and our product has the CE approval. We are just about to submit a Technical File for a new medical device based upon our existing product, but our current Notified Body is extremely busy and may well hold the project up.

    If we were to use a different Notified Body, would they accept our existing certifications and just review the Technical File to approve the product, or will they need to audit our Quality Management System also?

    Regards,

    JoCam
     
    Jo Campbell, Oct 15, 2015
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  2. Somashekar

    Somashekar Moderator Staff Member

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    One known devil is better than another unknown...
    I am not sure if the other notified body will be lenient, in the present context of NB surveillance.
    Two options.
    1. Will they talk with you about any premium cost for speedy services
    2. Can you CE mark the new medical device as it is based on the existing product and subject the technical file for review in the annual MDD assessment time.
    If your CE mark is through the route of full quality assurance Annex II, why not use option 2.
     
    Somashekar, Oct 15, 2015
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  3. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    Ask the NB you want to use. Each has its own set of rules, policies and procedures and based what I've seen on in other replies to similar questions there appears to be little consensus.
     
    Jim Hagenbaugh, Oct 15, 2015
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  4. JCIC49

    JCIC49 Member

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    Can I suggest that you talk to your notified body over the timelines, as I think you will find that most if not all NB are having issues, I have heard of one where they have only 20 auditors to cover more than a 1000 customers. Also has already been said in depending on the classification, they might accept to allow you to CE mark based on your existing scope of certification and review and next audit.

    I am aware of companies that of the ISO certification from a notified body to that which has issued the CE mark, but not to have different NB for CE marking.
     
    JCIC49, Oct 16, 2015
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  5. Jo Campbell

    Jo Campbell Member

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    Thank you for your reply. I feel that we should stick with the existing Notified Body as I'm also aware that all are under pressure at the moment, however I have been asked to investigate. On the subject of self-certification, our device is a class IIb, so I'm not sure we would be able to.

    Jo
     
    Jo Campbell, Oct 20, 2015
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  6. Somashekar

    Somashekar Moderator Staff Member

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    It is not self-certification. As your device is a new variant of an already CE marked device, and you are following the Annex II route for the CE mark, you could very well CE mark you new variant based on the additions you make in the technical file with details of changes and how the essential requirements are addressed, and you get the technical file reviewed in your upcoming MDD assessment. You are not creating an other new technical file. Discuss with your present good NB.
     
    Somashekar, Oct 20, 2015
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  7. pdzip

    pdzip New Member

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    Some notified bodies expedite reviews for a double fee. In theory, you can obtain an Annex III class IIb (EC type examination) certificate from Notified Body A and use your annex V (production quality assurance) from Notified Body B. That is perfectly within the scope of the MDD.

    In the long run, I expect you want to wait for your current NB to have time, or switch NB altogether. Changing to Annex II late in the game isn't going to help you much in my opinion but may help in the future
     
    pdzip, Jan 22, 2016
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    Jo Campbell likes this.