Get more clarity about Art. 117 and how we work
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).
Under the MDR, applicants must ensure compliance of the device component with Annex I GSPRs, with a Notified Body Opinion required where the device is not CE marked or not Class I. Understanding when an NBOp is required—and how to achieve compliance—is essential for successful EU market access.
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Article 117 - Documentation submission best practice guidelines.
This technical documentation submission guidance is aligned to the requirements of (EU) 2017/745 Medical Devices Regulation (MDR) Annex I and follows the structure given in Annex II of (EU) 2017/745.
This document draws on BSI’s extensive experience in the conduct of Article 117 and covers:
• Submission and Technical Documentation contents.
• Submission method.
• Document format.
• Additional topics to consider when preparing Technical Documentation for submission.
