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. 

Medicinal dossier guidance

Medicinal dossier guidance

Download our guidance for devices which incorporate an ancillary medicinal substance and fall under Rule 14 of EU 2017/745 (MDR).

Download the guidance >

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.

Read more on this article >

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