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).
Watch our Webinar to hear Dr Jennifer Durrant, Global Head of Medicinal and Biologics and Dr Jonathan Sutch, Medicinal Technical Specialist about BSI’s perspective on Article 117 and drug-device combination products.
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