Clinical Engineering Advisor
AI-powered MDR/IVDR compliance support for Irish hospital staff
Important Disclaimer
This AI assistant provides guidance based on current HSE and EU regulations but is not an official legal interpretation. For formal certification and compliance, complete mandatory training on HSeLanD and consult the latest HPRA (Health Products Regulatory Authority) publications.
Chat with Clinical Engineering Advisor
Chat EnabledWhat I Can Help With
- •MDR/IVDR classification questions
- •UDI and traceability requirements
- •Implant card obligations (Article 18)
- •In-house manufacturing exemptions
- •Laboratory developed test (LDT) rules
- •Incident reporting procedures
- •Compliance deadlines and transitions
Try Asking
"What is the difference between Class I and Class III devices?"
"What do I do if equipment malfunctions during a procedure?"
"Can we still use our in-house lab assays under IVDR?"
"When is EUDAMED becoming mandatory?"
Official Channels
→ HPRA (Ireland)→ HSeLanD Training Portal→ EUDAMED Database
For incidents, use NIMS (National Incident Management System) and contact your hospital's Risk Manager.