Regulatory Open Forum

 View Only

  • 1.  Contract Manufacturer only Labelling and Packaging?

    Posted 28-Feb-2022 14:35

    G'day to you,

    I would like to get your view on the following scenario related to a medical device Labeling and Packaging:

     

    Would it be compliant with the regulations (for example, QSR, MDR, etc) if Contract manufacturer A can ship the device without the labeling to another Contract Manufacturer B, and then the Contract manufacturer B applies the label to the device (UDI) whether the device is an RUO device or a Diagnostic Device and then packages and ship the device to the end customer.

    If the Contract Manufacturer B list their Establishment registration with the FDA would be sufficient from the USA ? what about EU is there any specific requirements? would this contract manufacturer be considered as the "Contract Packager" who can label and package?

    I would like to confirm whether a Contract manufacturer can perform only the Labelling (UDI) and Packaging?


    Thank you!




    ------------------------------
    Ram

    ------------------------------


  • 2.  RE: Contract Manufacturer only Labelling and Packaging?

    Posted 01-Mar-2022 02:30
    Hello Ram,

    A Contract Manufacturer or external supplier can perform any activity for a company, this is more defined by the company themselves.  For the FDA indeed a company who only performs packaging and labelling could be considered a Contract Manufacturer and register with the US FDA.  However, this Contract Manufacturer can then be subject to FDA inspections.  Some companies are not willing to have that exposure, therefore, they would not register and would not believe they need to register.  There is not a definitive definition of a Contract Manufacturer, so it would be recommended to clearly define in your own quality system, supplier management, what would constitute a contract manufacturer, and what they requirements are from a regulatory perspective.  Keep in mind too, in the US the UDI is done by the Labeller or the company who physically places the labels on the product, so this puts a little twist in the situation as well.  In Europe, there is no such definition and suppliers are not regulated under the EU MDR/EU IVDR.  It is completely the medical device manufacturer to manage any supplier, external suppliers, or contract manufacturers.

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

    Original Message


  • 3.  RE: Contract Manufacturer only Labelling and Packaging?

    Posted 02-Mar-2022 10:23
    Hi Ram,
    With respect to the labeler, under the EU-MDR, it might be considered an "economic operator" since you state that the labeler would ship the device to the customer.  The labeler might be considered a distributor/warehousing which falls under the title of economic operator.  Also, the labeler might be subject to audits by the Notified body of manufacturer since it will be considered a critical supplier.  

    The term "economic operators" is defined in EU MDR 2017/745 as "a manufacturer, an authorized representative, an importer, a distributor or a person" that is part of the product supply chain. This includes, for example, manufacturers, importers, distributors, and warehousing facilities.

    ------------------------------
    Angel Diaz
    Staff QA Assessment Specialist
    Plano TX
    United States
    ------------------------------

    Original Message


  • 4.  RE: Contract Manufacturer only Labelling and Packaging?

    Posted 02-Mar-2022 18:25
    Hi Angel,

    Thank you for your comments related to EU-MDR, very much appreciated!

    Thank you

    ------------------------------
    Ramakrishnan Kannan
    Clyde North VIC
    Australia
    ------------------------------

    Original Message


  • 5.  RE: Contract Manufacturer only Labelling and Packaging?

    Posted 02-Mar-2022 18:22
    Hi Richard,

    Thank you for your response, much appreciated. My understanding was inline with your view , but certainly your note about the Quality system- Supplier management SOP defining what constitute a contract manufacture is a good one , which I made a note of to update.

    Thank you.

    ------------------------------
    Ramakrishnan Kannan
    Clyde North VIC
    Australia
    ------------------------------

    Original Message


  • 6.  RE: Contract Manufacturer only Labelling and Packaging?

    Posted 02-Mar-2022 23:06
    Hi Richard,

    In my earlier email, I forgot to mention this:

    Reference : "Keep in mind too, in the US the UDI is done by the Labeller or the company who physically places the labels on the product, so this puts a little twist in the situation as well" 

    What is the twist you are inferring to , could you please clarify ? 

    Thank you

    ------------------------------
    Ramakrishnan
    ------------------------------

    Original Message


Related Content