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  • 1.  EU MDR - Notified Body (NB) Application

    Posted 04-Jan-2023 16:55
    Hi everyone!
    Happy New Year!

    I have a question, that may be silly. But I still thought I'd ask for my knowledge. 

    I am working for a manufacturing company and we are trying to secure a Notified Body for CE certification. The application forms for all Notified Body includes a question, "does the manufacturer uses a consultant for manufacturing process, marketing, regulatory or quality process."

    I understand about contractors/ sub contractors, and vendors,  but say if the company uses contractors from other consulting organization, like Emergo or other such service organizations, would that need to be included under consulting question? , If yes, would that make a difference in the cost or timeline for CE marking?

    Thanks in advance for helping me understand !

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    Vinoda Palanisamy
    Senior Regulatory Affairs Specialist
    Dallas TX
    United States
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  • 2.  RE: EU MDR - Notified Body (NB) Application

    Posted 05-Jan-2023 01:33
    Hello Vinoda.

    Indeed the question does query if consulting services are used for significant activities such as manufacturing validations, third party marketing/labelling, and third party regulatory consulting.  This gives the Notified Body (NB) an idea of what external processes or activities are performed by an external organisation.  As an example, some companies like virtual manufacturers outsource a significant portion of quality and regulatory activities like internal audits and submissions to external organisations.  It generally does not make a difference in the cost or timeline of CE Marking, allows the NB to see what activities are done external to the company.  It would be significant activities, so really depends on what consulting organisations you may list for the question.

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


  • 3.  RE: EU MDR - Notified Body (NB) Application

    Posted 05-Jan-2023 01:50

    Hi Vinoda,

    I also asked that question many times, but there was no satisfying answer so far. So here is my personal interpretation:

    Notified Bodies receive a huge load of requests for conformity assessments. A lot of the applied technical documentations are insufficient (see also https://www.team-nb.org/wp-content/uploads/2022/10/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V1-20221005.pdf, page 3, General Considerations).

    Notified Bodies are commercial companies, they need to be efficient in order to earn money. With every insufficient technical documentation, they have additional efforts in communication and re-evaluations. Of course, they are happier with valid technical documentation of high quality. So, guess why they ask for involved consultants! They might use this information for the preselection and prioritization of applications...

    Best regards
    Christian



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    Christian Rosenzweig
    Consultant
    Marburg
    Germany
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    Original Message


  • 4.  RE: EU MDR - Notified Body (NB) Application

    Posted 05-Jan-2023 21:07
    Hi Vinoda,

    Reading your question looks like if you're using Emergo or any such services then they may be your Authorized Representative and that information would need to be shared with NB.

    BR,
    Jinali

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    Jinali Bhavsar RAC
    Sr Regulatory Affairs Specialist II
    San Jose CA
    United States
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    Original Message


  • 5.  RE: EU MDR - Notified Body (NB) Application

    Posted 06-Jan-2023 06:20

    Hi Vinoda

    Having worked for a NB, hopefully I can support on the motives of the question.

    I agree with Richard's comments around the NB needing to understand your outsourcing etc. However, the main reason for asking this question is around the rules on conflict of interest (similarly for ISO 13845 certification services). A NB already under the Directives needed to show (i.e. it needed to be auditable to NCAs) that they (the specific reviewers, auditors, decision makers etc) involved do not have a conflict of interest with the company or devices under the services being conducted. The rules on conflict of interest and impartiality have become more 'stringent' i.e. more fully defined under the MDR/IVDR - see Annex VII section 1.2. These requirements of impartiality have to be demonstrated and be auditable at all stages of conformity assessment; hence the question/s at application stage that can raise any flags in planning & assignment of personnel. Some NBs are now moving away from using external resources completely as part of their activities, because of complications of CoI and meeting the MDR/IVDR requirements for impartiality. ["The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities. The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer.]

    I would further comment that the use of consultants as you say, should help with quality of submissions; and a NB would definitely not be against use of consultants, if it helps increase quality and the review efficiency. Also to comment that NBs do not use the use/or not of consultants to prioritize applications.
    I trust this helps.



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    Erica Conway
    Vice President, IVD Regulatory Affairs - Europe, MCRA
    United Kingdom
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    Original Message


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