Drug-device combination products under MDR Article 117
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).
BSI has a dedicated Medicinal and Biologics team, which provides guidance on drug-device combination products, conformity assessments of medical devices with ancillary medicinal substances (MDR Rule 14), and substance-based medical devices (MDR Rule 21).
Led by Dr J Durrant, Global Head of Medicinal and Biologics, who worked on the BSI General Devices team for over nine years previously, the team has over 55 years' combined experience in drug development, Good Manufacturing Procedures (GMP) systems and controls, and Quality by Design (QBD).
