- Search BSI
- Verify a Certificate
Suggested region and language based on your location
Your current region and language
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).
This course will help you:
By the end of this course you will be able to:
• Regulatory Affairs
• Design and Development
• Clinical Affairs Specialists
• Quality Management
• Quality Assurance
Pre-requisites:
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.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Reach out and see how we can help guide you on your path to sustainable operational success.