Medicinal dossier guidance
Download our guidance for devices which incorporate an ancillary medicinal substance and fall under Rule 14 of EU 2017/745 (MDR).
Drug-device combination products under MDR Article 117
Drug-device combination products under MDR Article 117
Are you a manufacturer of drug-device combination products?
Introduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the market as an integral device and marketing them as a “medicinal product” to seek a Notified Body Opinion (NBOp).
The notified body then confirms whether the device is compliant with the relevant General Safety and Performance Requirements (GSPR) and provides an NBOp Report to the manufacturer to include in the Market Authorisation Application (MAA).
Examples of drug-device combination products requiring NBOp include autoinjectors, inhalers, pre-filled nebulisers, pre-filled pens, pre-filled syringes and transdermal patches.
Manufacturers of combination products will need to obtain the services of a Notified Body; come and talk to BSI early in your planning.
Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.Resources to support you
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Brochure: download to learn about combination products >Learn about the application process for obtaining your Notified Body Opinion
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Webinar: watch on demand >BSI's perspectives on Article 117 and drug device combinations
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Journal: download to learn more >Read about combination products under the MDR including Article 117
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Request more information >Streamline your compliance process with BSI’s Compliance Navigator
