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.