Understanding Regulation EU 2017 745 Article 117 for Combination Devices

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.1 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 of 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.

Speakers:

Ibim Tariah

Technical Business Development Director – Medical Devices, SGS North America

Dr Tariah’s European regulatory affairs experience spans over 25 years and includes knowledge of combination devices incorporating biologics, drugs and drug-biologics together with Quality Management Systems Assessment of Medical Devices. His expertise lies in innovative non-active vascular, orthopaedic & dental, and other long-term implantable devices.

Greg Jacobson

Sales Director - Medical Devices, SGS

Greg Jacobson is the Director of Sales for the medical division at SGS North America. As a senior sales and medical device professional, he contributes to strategy, recommends resourcing requirements, and improves sales processes to drive client satisfaction. Greg has many years of experience in medical devices certification sales, where in the last 10 years he was responsible for managing high-risk device accounts. He has also held other sales roles both inside and outside of the TIC Industry.

 

For further information, please contact:

Dominic James
Marketing Assistant
t: +1-862-339-6737