Regulatory Open Forum

 View Only

  • 1.  Contract manufacturer MDR

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jan-2020 13:07
    This message was posted by a user wishing to remain anonymous

    ​Hi Everyone,

    We are contract manufacturers and need to add a new procedure to our system based on the EU MDR. Does anyone know what article explains the specifics? IF you have an article or white paper that specifically defines contract manufacturers requirements please share.

    Thanks!


  • 2.  RE: Contract manufacturer MDR

    Posted 23-Jan-2020 21:31
    I expect most of your requirements would be (should be) specified in those contracts.

    Article 10 gives requirements for the legal manufacturer, including
    ​

    9. Manufacturers shall ensure that procedures are in place to keep series production in conformity...
    The quality management system shall address at least the following aspects: ...
    (d) resource management, including selection and control of suppliers and sub-contractors;

    and

    15. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1)


    There are also some requirements around notified body audits of manufacturers including visits to the suppliers and subcontractors.



    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 3.  RE: Contract manufacturer MDR

    Posted 24-Jan-2020 02:35
    ​I think that Ann already gave a nice overview of the requirements for the legal manufacturer regarding the involvement of contract manufacturer(s). In contrast to the new legal responsibilities of the other economic operators (importer, distributor) the MDR does not pay specific attention to suppliers and subcontractors of legal manufacturers, other than the requirements Ann already mentioned and these are not directly addressed at the suppliers and subcontractors.
    The legal manufacturer is responsible for that what is produced and delivered by their suppliers and subcontractors for the medical devices to be marketed.

    From the MDR point of view suppliers and subcontractors are 'hidden behind the legal manufacturer' and do not have direct legal obligations.

    Clause 4.1.5 regarding outsourced processes and clause 7.4 Purchasing from ISO 13485:2016 give more detail on what is required to manage outsourced processes, but again from a legal manufacturers point of view.

    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: Contract manufacturer MDR

    Posted 24-Jan-2020 06:27
    Agree with Anne to look at Article 10, also Annex I, and also Annex IX.  As a contract manufacturer your main responsibility is product realisation of a finished medical device.  However, the Manufacturer (legal manufacturer) has to ensure all these controls are in place.  Therefore, from a supplier perspective you will want to work with the legal manufacturer to understand what processes and procedures need to be EU MDR compliant within your own quality management system.  From a purely manufacturing point of view, I do not see significant impact by the EU MDR regulation.  Though from a quality system process perspective, there are many considerations that need to be viewed.  A contact manufacturer often are viewed as a crucial supplier to a legal manufacturer and may be subject to audits by a Notified Body, so must be prepared for those instances as well.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 5.  RE: Contract manufacturer MDR

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2020 09:06
    This message was posted by a user wishing to remain anonymous

    ​Thank you All!
    Original Message


Related Content