Experienced medicinal drug consultations

Experienced medicinal drug consultations

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Medicinal and biologics
Medicinal and biologics
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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).

Visit our drug-device combination products webpage for more information on seeking an NBOp from BSI. 

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A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

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A dedicated Medicinal and Biologics team

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 Jennifer 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).

BSI issues first Article 117 Notified Body Opinion

BSI was the first in the world to issue an NBOp to a manufacturer under Article 117 of the MDR. This is thanks to the team for working incredibly hard to provide this expertise to clients.

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