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?
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.
- 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 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
- Training course notes
You’ll be awarded an internationally recognized BSI Training Academy certificate.