Regulatory Open Forum

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  • 1.  Critical Suppliers

    Posted 05-Feb-2021 02:29
    Hello,

    does anyone have an example of a contract addendum for critical suppliers to get their agreement for audits by your Notified Body?

    Greetings,
    Franky

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    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
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  • 2.  RE: Critical Suppliers

    Posted 06-Feb-2021 11:34
    Hello Franky

    This is what we use in the Quality Assurance Agreement we suggest to our customers (we are a service supplier):

    Audit Right

    Upon notice, the Supplier grants the Customer, its notified body, and authorities responsible for the Customers medical devices the right of inspection of its QMS. The Customer will share any findings of such inspections with the Supplier. 

    The Customer takes measures to ensure that all findings resulting from audits or inspections will remain confidential.

    The Supplier acknowledges that unannounced audits by notified bodies may be conducted without preliminary notice. The Supplier has knowledge of EU Commission Recommendation 2013/473/EU and accordingly the Supplier is prepared to receive unannounced audits of notified bodies and to grant access to its facilities and to all documentation related to the provision of the service.


    Best regards,

    Hans




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    Hans Strobel
    CEO
    dokspot GmbH
    Zürich, Switzerland
    www.dokspot.io
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  • 3.  RE: Critical Suppliers

    Posted 06-Feb-2021 13:19
    That is quite good wording Hans provided, we have something similar in our Agreement template.  Though I would add a comment which the Unannounced Audit recommendation is now incorporated into the EU MDR 2017/724 regulation so you can include that in your agreements.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: Critical Suppliers

    Posted 08-Feb-2021 02:49
    Thanks a lot

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    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
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  • 5.  RE: Critical Suppliers

    Posted 09-Feb-2021 08:41
      |   view attached
    here attached our template

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    YASSER ESTAFANOUS
    Director of RA/QA
    Winter Haven FL
    United States
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  • 6.  RE: Critical Suppliers

    Posted 10-Feb-2021 05:43
    Thanks

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    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
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  • 7.  RE: Critical Suppliers

    Posted 14-Feb-2021 16:10
    Hi Franky, 

    We have the following memorandum with our critical suppliers to comply with IVDR requirements. I hope this helps.  

    This memorandum has been created for all Canterbury Scientific Limited critical suppliers. This memorandum identifies the requirements for Notified Body to audit our critical suppliers, under our prudent attempt to achieve compliance to In Vitro Diagnostic Medical Device Regulation 2017/746 and requests you to kindly read and acknowledge the following. 

    Product registration: To place the product on the market in various countries, Canterbury Scientific Limited (CSL) must comply with applicable directives, regulations, and laws (e.g., the European In Vitro Diagnostic (IVD) Medical Device Directive 98/79/EEC or IVD Regulation 2017/746, US Food and Drug Act). Compliance to these directives, regulations, and laws may require information related to the product or manufacturing process to be submitted with relevant regulatory authorities (e.g., US Food and Drug Administration, European Commission, MHRA), authorized organizations, or by third parties commissioned by CSL. Supplier agrees to provide CSL with information related to the manufacturing, processing, finishing, testing, packaging, labeling, storage, or shipment as needed to register products in the intended countries where product will be placed on the market. 

    Third party audit: An audit or regulatory inspection may be required from time to time. This may involve the authority having jurisdiction over CSL according to the European In Vitro Diagnostic (IVD) Medical Device Directive 98/79/EEC or IVD Regulation 2017/746 or any other regulatory authority (e.g., US Food and Drug Administration, European Commission, MHRA) or authorized organization or by third parties commissioned by CSL. The regulatory authority may or may not announce the audit to CSL or the Supplier prior to the audit date (referred to as "unannounced audit"). Supplier must have a procedure in place to describe how the Supplier supports audits. 

    External audit support:  Supplier shall use their best efforts to answer specific questions relating to quality assurance, quality systems, and regulatory as soon as possible upon CSL's request.  Additionally, a copy of a record(s) is to be made available to CSL within two (2) business days upon request from CSL. These requests may be made to support external audits of CSL, such as an FDA inspection, Notified Body audits. In the event confidential information is requested by external regulatory authorities or governmental and external agencies (i.e. FDA, Notified Bodies), and permitted by the current regulations applicable for the product, files can be sent directly to the authorizing body without providing a copy to CSL. 

    Action by approving Official:

    I have reviewed the above-stated facts and concur with the requirements stated in this notification memorandum.




    ------------------------------
    Murtuza Bohari
    Quality and Regulatory Manager
    Canterbury Scientific Limited
    Christchurch, New Zealand
    mbohari@canterburyscientific.com
    +64 21756098
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