Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

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Scope of Article 117

In the Scope of Article 117

Out of Scope of Article 117

• Medicinal products that form an integral product with a medical device, where the action of the medicinal product is principal

• Combined ATMPs – Regulation 1394/2007

• Non-Integral Combinations

• Co-packaged devices with medicinal products • Cross-labelled products

Reference: Second subparagraph Article 1(8) and Article 1(9), MDR (EU) 2017/745

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Article 117 Medical Device Regulation

• Applicant to include in MAA • The results of the Conformity Assessment of the device (if CE Marked), or • The Notified Body opinion on the conformity of the non-CE marked device

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