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 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.