Article 117 medical devices
MDR Article 117 covers devices intended to administer a medicinal product, where they form a single integral product intended exclusively for use in the given combination and which is not reusable (drug-device combination products).
Introduced by the European Commission, MDR Article 117 requires manufacturers of these medicinal products to seek a Notified Body Opinion (NBOp). Once the Notified Body confirms whether the device is compliant with the relevant General Safety and Performance Requirements (GSPR) and provides a NBOp Report, the manufacturer can proceed with the Market Authorisation Application (MAA) for their medicinal product.
BSI was the first ever Notified Body to issue a NBOp to a manufacturer for a drug-device combination product under MDR Article 117. We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services (Standard and Dedicated) providing you with efficient pathways to bring your product to market.