EU IVDR LLM Assistant
EU IVDR LLM Assistant
AI-powered regulatory compliance guidance for In Vitro Diagnostic Regulation
Connecting…
Important: This tool produces AI-generated general information, not legal, regulatory, quality, or professional advice. Responses may be incomplete, outdated, or incorrect. Independently verify every output against the current IVDR text, European Commission and MDCG guidance, applicable standards, and advice from a qualified regulatory professional before making decisions. Do not rely on this tool as your sole source of compliance information.
Welcome! I'm your EU IVDR compliance assistant. I can help you understand In Vitro Diagnostic Regulation requirements including:
• Device classification (Classes A, B, C, D)
• Conformity assessment procedures
• Technical documentation requirements
• Clinical evidence and performance evaluation
• UDI registration and EUDAMED
• Vigilance and post-market surveillance
• Transition timelines and deadlines
• Notified body requirements
• Quality management systems (ISO 13485)
How can I assist you today?
• Device classification (Classes A, B, C, D)
• Conformity assessment procedures
• Technical documentation requirements
• Clinical evidence and performance evaluation
• UDI registration and EUDAMED
• Vigilance and post-market surveillance
• Transition timelines and deadlines
• Notified body requirements
• Quality management systems (ISO 13485)
How can I assist you today?
By using this assistant, you acknowledge that its outputs require independent professional review and verification.