Our Notified Body Opinion Service, Which We Offer Within The Scope Of Article 117 Of (EU) 2017/745 Medical Device Regulation, For Manufacturers To Market Their Drug-Device Combination Products As An Integrated Device
Article 117 of (EU) 2017/745 Medical Device Regulation (MDR) requires manufacturers who market drug-device combination products as an integrated device and market them as “medicinal products” to obtain a Notified Body Opinion (NBOp).
The NBOp is awarded as a result of an assessment carried out by the notified body regarding the compliance of the device part contained in the products in question with the relevant General Safety and Performance Requirements (GSPR) set out in Annex I of the MDR. Evaluation of test reports, risk management reports, clinical evaluation, biological evaluations and other reports to provide objective evidence of the compliance of an applicable GSPR constitutes documentation of compliance with the GSPR. The documentation is evaluated by UDEM A.Ş. for the compliance of the device for its intended use, taking into account the complexity of the device, relevant patient characteristics, and the clinical environment.
As UDEM A.Ş., we provide an independent NBOp in accordance with the legal framework as a result of evaluating the technical documentation of the relevant device.
What is the role of UDEM A.Ş. within the scope of MDR Article 117?
-It confirms whether the device complies with the relevant GSPR.
-It provides an NBOp report to the manufacturer to add to the application to be made before the relevant product is placed on the market.
*The opinion report for such a medical device includes an assessment of the device component with the relevant GSPR specified in MDR Annex I.
If you are a manufacturer of Drug-Device combination products, what should you do to receive MDR Article 117 assessment service from UDEM A.Ş.?
-For your first notified body opinion request;
First, verify that the device is within the scope of UDEM A.Ş.’s desgination via the link below.
If the device is within the scope of UDEM A.Ş.’s designation, you can access the MDRFRM.192 MDR Article 117 Application Form from the link below.
https://www.udem.com.tr/en/application-forms
-If a change in the medical device component of the medicinal product affects the GSPR compliance of the device, the opinion report must be revised. For your notified body opinion request regarding the change;
You can access the MDRFRM.45 Change Notification Form from the link below.
https://www.udem.com.tr/en/en-eu-2017-745-medical-device-regulation
MDR ARTICLE 117 NBOp PROCESS
MDR Article 117 NBOp process flow carried out by UDEM A.Ş. is briefly shown in the diagram below. The opinion report is prepared in Turkish and English by UDEM A.Ş.
UDEM Certificate
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