Course objective and outcome
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.
 
This 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).
 
Content

• 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

 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

Trainer
TBA