There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC), and will impose new requirements on manufacturers and other Economic Operators.
This long awaited text brings a number of significant changes to the regulatory requirements for IVD manufacturers, addressing the challenges posed by the IVD Directive. The changes include a new rule-based classification system, increased scrutiny of technical documentation, and improved traceability of devices through the supply chain.
Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).
How will I benefit?
This course will help you:
- Identify the requirements of the new IVD Regulation and how this will impact your organization and other operators
- Understand the significant changes that are being introduced by the new legislation
- Learn what needs to be revised in your current arrangements to meet 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
- 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
You will benefit from having a basic understanding of the IVD Regulation.
The course is aimed at delegates who already have a good knowledge of the existing IVD Directive.
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
- Training course notes