IVD Directive to IVD Regulation (IVDR) Transition training course

Who should attend?

• Medical device manufacturers, especially if your role is in:

• Regulatory Affairs
• Design and Development
• Clinical Affairs Specialists
• Quality Management
• Quality Assurance

• Authorized Representatives
• Economic Operators, including importers and distributors
• Consultants

What will I learn?

You will learn about the:

• Requirements and impacts of new IVDR
• Key aspects of the transition - from Directive to Regulation
• Changes to responsibilities of Economic Operators
• Significant changes introduce by the new IVDR
• Revised scope, risk-based classification, and conformity assessment
• Revised clinical expectations
• Managing the transition
• New expectations for post-market activities
• Technical documentation for compliance

How will I benefit?

On completion of this course, you will be able to:

• Identify the requirements of the IVDR and understand how this will impact your organization and other Economic Operators
• Understand the significant changes introduced by the IVDR and what won’t be affected
• Learn what needs to be revised in your current arrangements to ensure compliance
• Take steps to ensure that existing products CE marked under the IVD Directive comply with the IVDR
• Create a plan for your organization to transition to the new Regulation for new IVD product development.

What's included?

• Training course notes
• Lunch 
• Refreshments