Course Objectives
At the end of this workshop, participants will be able to:
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Describe the objectives and structure of the MDR.
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Identify the key differences between the requirements found in the former directives and the MDR.
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Explain the impact of the MDR requirements on economic operators, including manufacturers.
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Describe the different regulatory requirements through the life-cycle of a device (e.g., premarket, design and development, product realization, and postmarket).
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Identify the necessary steps to prepare an organization to follow the MDR.
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Plan a gap assessment to guide an organization to compliance.
Course Topics
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The objectives of the MDR, including the significance of replacing directives with a regulation
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Quality management system requirements in the MDR
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Device classification and conformity assessment route changes in the MDR
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Technical documentation requirements in the MDR
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Clinical evaluation process requirements in the MDR
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UDI and traceability requirements in the MDR
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Postmarket surveillance and reporting requirements in the MDR
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Life-cycle review of products linked to risk management and clinical evidence
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Auditing impact of the MDR
Highlighted Handouts and Resources
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Matrix of Annex I Requirements (MDD Essential Requirements Compared to MDR General Safety and Performance Requirements)
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MDR Implementation Quality Plan Tool
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A Pathfinder for the Medical Device Regulation and its Annexes, which serves as a table of contents for the 175+ page regulation
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EU Glossary with definitions of key terms
Who Should Attend
Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU.
Virtual Class Days
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This training is delivered as five consecutive half-day sessions.
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Daily sessions run from 1:00-5:00 p.m. Eastern Standard Time.
Virtual Half-Days:
5
In-Person Full-Days:
3
CEUs:
2.5