Drug-device combination products under MDR Article 117

Are you a manufacturer of drug-device combination products? If so, you need to be aware of the changes in Article 117 of the Medical Device Regulation (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.


Register for our free webinar on BSI’s perspectives on Article 117 and drug-device combinations

Join one of our webinars on 1 July 2020 to hear from Dr Jennifer Durrant, Global Head of Medicinal and Biologics and Dr Jonathan Sutch, Medicinal Technical Specialist about BSI’s perspectives on Article 117 and drug-device combination products.

Choose from one of two sessions:

Wednesday 1 July 2020
9:00– 10:00 BST

Register now

Wednesday 1 July 2020
16:00– 17:00 BST

Register now