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  • 1.  UDI - Combination Product(Drug-Device Combinations)

    Posted 20-Sep-2019 06:49
    Hi All,

    I just want to know certain things related to UDI requirements
    For US, Is that UDI is required for Combination Products(Drug-Device Combinations like Pre-Filled Pen, Pre-Filled Syringes)?, I have seen in CFR, its mentioned that for Combination Products there will be National Drug Code, Could anyone please give some clarity?
    For EU, As per MDR 2017/745, Is that UDI is required for Combination Products(Drug-Device Combinations like Pre-Filled Pen, Pre-Filled Syringes)?, Could anyone please give some clarity?


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    Adhithya Arumugasamy
    Senior Executive - Regulatory Affairs
    India
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  • 2.  RE: UDI - Combination Product(Drug-Device Combinations)

    Posted 20-Sep-2019 08:18
    21 CFR 801.30 describes some exceptions that might apply:

    (a) In general. The following types of devices are excepted from the requirement of § 801.20; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI):
    (11) A device packaged within the immediate container of a combination product or convenience kit, provided that the label of the combination product or convenience kit bears a UDI.

    (b) National Drug Code (NDC) Numbers. If a combination product properly bears an NDC number on its label-
    (1) The combination product is not subject to the requirements of § 801.20.
    (2) A device constituent of such a combination product whose components are physically, chemically, or otherwise combined or mixed and produced as a single entity as described by § 3.2(e)(1) of this chapter is not subject to the requirements of § 801.20.
    (3) Each device constituent of such a combination product, other than one described by § 3.2(e)(1) of this chapter, must bear a UDI on its label unless paragraph (a)(11) of this section applies.​

    Article 1 of the EU MDR says:

    6.This Regulation does not apply to:
    (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;

    And point 2 of Article 1 of Directive 2001/83/EC says:

    2. Medicinal product:
    (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
    (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: UDI - Combination Product(Drug-Device Combinations)

    Posted 20-Sep-2019 08:42
    Thank You Anne for your insights on UDI
    For US, Now I got clarity
    But for EU, However based on Principle mode of action of the product might be Medicinal Product or considered to be a device, But however if the Device is a single integral product with the drug which is intended to deliver the Medicinal substances administering to Human Body, that device constituent part has to comply with Annex I GSPR of MDR 2017/745 and to get Notified Body Opinion for that combination Product(only device constituent parts), In that case whether UDI requirements is required or not?

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    Adhithya A
    Senior Executive - Regulatory Affairs
    Thane
    India
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    Original Message


  • 4.  RE: UDI - Combination Product(Drug-Device Combinations)

    Posted 21-Sep-2019 07:47

    Adhithya,

     

    The information that Anne provided is spot on and clearly shows that "single-entity" Combination Products (USA) or "integrated" Drug Device Combinations (DDC- EU) are exempt from UDI requirements.  As finished products these are considered drugs, and must be approved (NDA or MAA) and labeled as drugs.   This would apply to products like prefilled syringes, prefilled autoinjectors and prefilled pens that come to the user as one integral (not to be separated) product.

     

    The additional requirement in the MDD (Where a device is intended to administer a medicinal product .... If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, .... relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.)

    The MDR states in a similar way that "if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, ..... the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.

     

    As such, the information submitted to the Competent authorities must establish that the safety and performance requirements of the device consistent with the MDD or MDR. have been met. The change (other than from EPR to GSPR) is that for integral DCCs a NB body opinion as to compliance with the GSPR must also be provided to the Competent Authority (i.e. EMA).  This is outlined in Article 117 of the MDR.

     

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    Office: +1-239-244-1448

    Cell: +1-239-994-6488

    Email: leichter@plbiomedical.com

     




    Original Message


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