This webinar introduces the pathways and conditions for medical device legal manufacturers to keep marketing their devices to the EU following the MDD validity extension process introduced by the MDR Amendment 2023/607.

Objective

• Understanding the Current EU regulatory framework, with focus on the MDD extension process (including the analysis of the legal text, definitions, pathways, conditions), SGS’ implementation
• Providing guidance on typical special cases: legal manufacturer and notified body changes
• Providing summary of unknown implementation details and strategy for dealing with the incomplete information

Agenda

• Introduction to the MDR Amendment 2023/607
• Definitions
• Eligibility pathways and conditions
• SGS’ process for MDD validity extension
• Handling typical special cases (legal manufacturer and notified body changes)
• Disclaimer on known unknowns, handling uncertainty
• Q&A

Target Audience: This webinar is aimed at regulatory professionals of MDD certified* medical device legal manufacturers. 
*Note: This webinar is not only intended for manufacturers currently or previously certified by SGS. Manufacturers with expired MDD certificates, regardless of their MDR application status, are also in the intended audience.

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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