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  • 1.  Notified Body Opinion for single integral drug-device combination products

    Posted 08-Feb-2023 11:15
    Edited by May Meng 08-Feb-2023 11:28
    Dear all
    I have 2 questions regarding getting Notified body opinion for single integral drug-device combination products.

    • Should the non-EU MAH for the DDC apply with a Notified body directly, or through an European Representative?  

    • Can the device constituent part manufacturer submit a Device Master File directly to the Notified body to support the technical documentation for NBOp? 

    Appreciate if you could share your experience. Thank you very much in advance.

    May

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    May Meng, PhD, RAC
    Senior Consultant
    Oxford
    United Kingdom
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  • 2.  RE: Notified Body Opinion for single integral drug-device combination products

    Posted 08-Feb-2023 12:39
    Hi May,
    single integral drug-device combination products. are regulated under medicinal products framework. European rep doesn't have a role here, as it is not considered medical device. MAH can directly work with notified body to a quote on Notified body opinion quote. The Notified Body Opinion review could take 2-3 months plus clock stops for questions.

    Device constituent Manufacturer can provide technical file directly to NB. There is no device master file, but technical file itself is the device file. 
    hope this helps

    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Notified Body Opinion for single integral drug-device combination products

    Posted 08-Feb-2023 13:42
    Dear Raje
    Thank you very much for sharing your experience/thoughts on my questions. Really appreciate your input.

    To further clarify, am I right to say that the 'MAH' could be an outsourced third-party legal entity that act on behalf of the DDC MAH in the communication with Notified bodies? 

    Best regards
    May​

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    May Meng, PhD, RAC
    Senior Consultant
    Oxford
    United Kingdom
    ------------------------------

    Original Message


  • 4.  RE: Notified Body Opinion for single integral drug-device combination products

    Posted 09-Feb-2023 01:44

    Hello May,

    The Manufacturer (non-EU Market Authorisation Holder) can either request directly from the Notified Body or go through their Authorised Representative (AR) - and this applies under the Article 117 of the EU MDR.  Just note, this framework is not well established today and depending on the Notified Body may have some challenges and take a moderate to long period of time for the "opinion".

    In most cases, the Manufacturer of the medical device constituent/part would submit the Technical Documentation file of the device directly to the Notified Body for the review and opinion.  The Technical Documentation file is described in Annex II of the EU MDR regulation.

    In practicality, you could have the Manufacturer represented by an outsourced third-party such as the medicinal product company or a consulting firm, but ensure the lines of communication are clear between all of the entities.  Again, this framework for Notified Body opinion on medical devices of drug-device combined products is not well established, so it actually might be better to work with an experienced entity dealing with the Notified Body.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Notified Body Opinion for single integral drug-device combination products

    Posted 09-Feb-2023 10:02

    Dear Raje, Richard, Beat and Neil

    Thank you for sharing your precious knowledge and experience on my questions regarding DDCs under EU article 117. I am so happy and lucky to be supported by all of you-my super VIPs ❤️ on combination products!  

     Best regards

    May



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    May Meng, PhD, RAC
    Senior Consultant
    Oxford
    United Kingdom
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    Original Message


  • 6.  RE: Notified Body Opinion for single integral drug-device combination products

    Posted 09-Feb-2023 03:22

    Dear May,

    An Authorized Representative is not required for this type of products, so the MAH can deal directly with a Notified Body.

    In my experience (so far we helped obtaining 14 Notified Body Opinions) Notified Bodies required the docments that provide objective evidence that the device meets the GSPR directly from the MAH, not the device manufacturer. The device manufacturer normally doesn't have the data regarding extractables, leachables, human factors etc.

    Hope this helps!

    Cheers, Beat



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    Beat Steffen, FRAPS
    Founder & CEO
    Oberkirch
    Switzerland
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    Original Message


  • 7.  RE: Notified Body Opinion for single integral drug-device combination products

    Posted 09-Feb-2023 04:25

    Hi May:

    Agree with most of the comments. I would draw out:

    1. Notified Body availability: not all NBs have the resource to give an opinion on every product in a reasonable time. For example: last year on major NB informed us 6 months after agreeing a review date that that no longer had the resource to provide an opinion this year. They is a high "churn" of experts in these fields and priority is currently placed on continuity of existing products over new products in line with the Commission's (belated) concerns.
    2. Usually the file needs to be from the MAH holder (or their final manufacturing entity before drug and device parts are integrated). This is because all device component manufacturing operations (testing, labeling, handling/storage and release "for filling") have to be covered, as well as testing with the final drug-part. Sub-contractors rarely have the knowledge of the combo product to assess GSPR compliance as the device is intended to be used (as Beat mentioned) but crucially deterioration over time of device performance from extended contact with the drug component.

    Finally talk early to NBs and expect to have to "shop around" to find an NB with capacity to meet your timescale, has sufficient expertise on the particular product and will accept your overall testing approach (rather than insisting on their standard process).

    Good luck! In my opinion this is one of the trickiest areas to get good service from an NB!

    Neil



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    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


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