EU MDR 2017/745: Key Insights for Active Medical Device Manufacturers in Middle East

With the increasing regulatory demands in the European Union, manufacturers of active medical devices in the Middle East who need to market their products in the European Union need to stay aligned with the EU MDR 2017/745 requirements to ensure continued market access.

Join Shoaib Ahmed, Medical Devices Expert at SGS, in this region-focused webinar that provides a clear overview of the regulatory obligations under EU MDR and what they mean for companies operating in GCC and Middle East region. From classification and CE marking to technical files and post-market follow-up—this session will help your team understand the essential steps to meet EU expectations and maintain product approval in the EU market.

Objective

By the end of this webinar, attendees will have a solid understanding of how to navigate EU MDR 2017/745 requirements for active medical devices intended for the European market and more:

• Understand how EU MDR impacts Middle East manufacturers and the essential steps to comply
• Identify the classification, CE marking, and documentation requirements for active devices
• Gain clarity on post-market responsibilities including PMS, PMCF, and vigilance activities 

Agenda

• Overview of EU MDR 2017/745 and its impact on active devices 
• How EU MDR affects manufacturers in the Middle East
• Understanding classification rules for active devices (Chapter III)
• CE marking and conformity assessment routes
• Products testing: Safety, Performance, EMI/EMC testing
• Technical documentation: structure and content
• Clinical evaluation and performance data requirements
• UDI, labeling, and EUDAMED updates
• Post-market duties: PMS, PMCF & vigilance
• Open Q&A

Who should attend?

• Medical device manufacturers in the Middle East
• Regulatory affairs professionals
• Quality and compliance managers
• Product development and documentation teams
• Companies seeking or maintaining EU market approval for active devices

Language: English

Cost: No Charge

Register today!

Can't make a live session? Register here and receive a complimentary recording after the live event.