In the EU, Article 117 of Regulation (EU) 2017/745 (MDR) requires a marketing authorization holder of a medicinal product that incorporates a nonreusable medical device (or integral drug-device combination product such as a prefilled syringe) to obtain an NBOp confirming the device part is compliant with the relevant general safety and performance requirements (GSPR)2 in Annex I of the EU MDR. The positive NBOp is then included in the marketing authorization application (MAA) or variation, as applicable.

This webinar addresses regulatory considerations associated with notified body opinion (NBOp) in accordance with Article 117 of the EU Medical Devices Regulation (EU MDR)1 for medicinal products that incorporate a nonreusable medical device.

Objective

The objective of this webinar is to

• Define Medical Devices: MDD vs. MDR
• Provide Background: Notified Body role in Drug-Device Combination under MDR
• Detail MDR Article 117 Requirements and products in scope
• Explain General Safety and Performance Requirements
• Explain Transition Provisions: Application deadline May 26th, 2024

Agenda

• Definition of Medical Devices: MDD vs. MDR
• Background: Notified Body role in Drug-Device Combination under MDR
• MDR Article 117 Requirements and products in scope
• General Safety and Performance Requirements
• Transition Provisions: Application deadline May 26th, 2024

Target Audience: This webinar is aimed at regulatory professionals of legal manufacturers of medical devices who intend to continue placing products on the EU market until the end of the transition on 31st December 2028.

Language: English
Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event. For further information, please contact: KN.NAM.Marketing@sgs.com

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