Module 16 2024

10/17/2024

Where are we with the EU-MDR?

European Post-Market Surveillance Requirements

Stephan Buttron, Buttron Consulting Berlin, Germany

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The Organisation for Professionals in Regulatory Affairs The Organisation for

10/17/2024 Confidential

Professionals i Regulatory Affairs

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Agenda

• Summary of current EU-MDR Regulatory Framework

MDR Extensions Timelines and Milestones

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Article 83 PMS System Requirements

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Article 84 & Annex III PMS Planning

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Article 85 & 86 PMS Reporting

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TOPICS

Annex XIV - Post-Market Clinical Follow Up

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MDR Requirements for Economic Operators

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OMS Guidance Document

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Summary and Learning Outcome

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Q&A

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The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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