MDR Article 117

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  • MDR Article 117 requires manufacturers of drug-device combination products to seek Notified Body Opinion

    The Medicines Directive 2001/83 has been significantly amended by the new Medical Device Regulation (MDR 2017/745). If you are a manufacturer of drug-device combination products regulated as medicinal products under Medicines Directive 2001/83 you need to be aware of Article 117 of the new regulation.

    Article 117 of Regulation (EU) 2017/745 requires manufacturers of medicinal products which incorporate devices (drug-device combination products) to demonstrate that the device component of a drug-device combination product conforms to the General Safety and Performance Requirements (GSPRs) of Annex I of the MDR by either using a CE certified product, or by self-declaration for applicable devices or the provision of a Notified Body Opinion (NBOp). As a Notified Body, DEKRA can issue this mandatory NBOp to the manufacturer.

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  • The role of a Notified Body

    Because of the growing complexity of drug-device combinations (as technology progresses, device parts can now include software, applications or other active components) the European Commission has introduced Notified Bodies into the review process of drug-device combination products to assess the safety and performance of device components. Previously the drug competent authorities were responsible for reviewing all aspects but this has now changed with the introduction of the MDR.

    Drug-device combinations that will require an NBOp

    If Article 117 is to be applicable, three cumulative conditions need to be satisfied:
    When placed on the market…
    • the device and medicinal product form a single integral product;
    • the device and medicinal product are to be used exclusively in the given combination;
    • the device is not reusable.

    Examples of drug-device combination products that will require an NBOp are:

    • Dry powder inhalers and pressurized metered dose inhalers, preassembled with a medicinal product with single or multiple doses and not intended to be re-filled.
    • Single-use pre-filled pens or single-use pre-filled injectors (including auto injectors) not intended to be re-filled once the initial provided doses are exhausted.
    • Single use pre-filled syringes.
    • Transdermal patches and sub dermal implantable devices whose primary purpose is to release the medicinal product.

  • Why DEKRA?

    Europe

    European Notified Body

    We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices

    Recognized

    Recognized auditing organization for MDSAP

    The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. DEKRA is a recognized auditing organization for MDSAP.

    Globally recognized

    Globally recognized certification body

    With a global network of offices and state-of-the-art laboratories, we can help you to gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia, and Japan.

  • NBOp Report

    A NB conformity assessment of drug-device combination products falling within the scope of Art 117 consists of a review of the technical documentation against all relevant General Safety and Performance Requirements (GSPRs). These GSPRs are identified in Annex I of the MDR. After scheduling and a successful check on the completeness of the technical documentation, a first review time line is typically 6 to 8 weeks. The duration of the entire review process depends on the quality of the technical documentation, the number of review rounds and number of questions that the notified body needs to ask in each review round, as well as the manufacturer’s responsiveness in adequately addressing the questions.

    Annex II of the MDR provides guidance on which documents are required to be submitted to the Notified Body. In addition, TEAM-NB has issued a position paper on Article 117 (Team-NB Position Paper on Documentation Requirements for Drug-Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745). DEKRA actively participates in the Article 117 Working Group of TEAM-NB, which is currently working on additional position papers.

    After a successful completion of the review, a Notified Body such as DEKRA will issue an NBOp Report with a confirmation whether the device component is compliant with the relevant GSPRs of MDR 2017/745. This opinion can then be included in the Marketing Authorization Application (MAA) of the drug-device combination product in support of a market authorization request submitted to a drug competent authority.

    Contact DEKRA for more information

    If you are a manufacturer of drug-device combination products regulated as medicinal products you need to be aware that MDR  2017/745 Article 117 amends the Directive 2001/83 significantly by requiring an NBOp from a Notified Body in order to get marketing authorization for your medicinal product. This amendment comes into force as of 26 May 2021. It is therefore important to engage with your NB of choice in a timely manner.  DEKRA now offers the service to provide manufacturers with an NBOp, in addition to the existing certification services. For more information about the new regulatory requirements set forth in Article 117 or for obtaining an NBOp, get in touch with our drug-device combination experts at DEKRA.

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