Course Aim:

Understand the key changes of the new IVD Regulation, which replaces the IVD Directive, and how this will impact your organization for the CE marking of In Vitro Diagnostic Medical Devices (IVDs).

Course Description:

There are significant changes in the European legislation applicable to IVDs. The IVD Regulation has replaced the IVD Directive, which will impose new requirements on manufacturers and other economic operators. By attending this course, you’ll discover the new requirements and how these will affect your organization.

How will I benefit?

This course will help you:

• Identify the requirements of the new IVD Regulation and understand how this will impact your organization and other operators
• Understand the significant changes that are being introduced by the new legislation and what won’t be effected
• 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 new Regulation

Create a plan for your organization to transition to the new Regulation for new IVD product development

What will I learn?

By the end of this course you will be able to:

• Explain the background to the IVD Regulation and why the IVD Directive is being replaced
• Recognize increased responsibilities of economic operators
• Differentiate between the requirements of the IVD Directive and Regulation, including the classification rules under the new IVD Regulation
• Recognize conformity assessment routes available under the new Regulation in order to CE mark your products
• Identify new requirements for clinical evidence and post-market performance follow-up
• Explain the importance of technical documentation for compliance with the new Regulation and how the Summary of Technical Documentation (STED) may be used

Who should attend?

QA regulatory and development personnel involved in CE marking of IVD devices for the European market.

Duration:

1 day

Prerequisites:

Delegates will benefit from a basic understanding of IVD Regulation.