What You Will Learn
At the end of this workshop, participants will be able to:
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Describe IVDR objectives and structure, and identify key differences between the IVDD and IVDR.
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Explain the impact of the new IVDR requirements on economic operators, including manufacturers.
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Describe the various regulatory requirements through the life cycle of a device (e.g., premarket, design and development, product realization, and postmarket).
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Explain new stipulations for the clinical evaluation process and risk management, including performance evaluation.
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Understand new device classification rules plus technical documentation, UDI, and traceability specifications.
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Articulate postmarket surveillance and reporting mandates in the IVDR.
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Identify the steps needed to prepare an organization to transition to the IVDR.
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Plan a gap assessment to transition an organization to compliance and understand the impact on internal auditing.
Who Should Attend
Anyone who works for manufacturers that market in vitro diagnostics in the EU.
Number of Days:
3
CEUs:
2.5