Medicinal dossier guidance
Download our guidance for devices which incorporate an ancillary medicinal substance and fall under Rule 14 of EU 2017/745 (MDR).
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 the Market Authorisation Application (MAA).
Visit our drug-device combination products webpage for more information on seeking an NBOp from BSI.