MDR/IVDR Classification Checker
Answer a few questions to get an indicative classification. This is guidance only - always verify with the full classification rules in Annex VIII.
Question 1
What type of device is this?
Vigilance Reporting Timeline Calculator
Calculate manufacturer reporting deadlines based on incident type and date of awareness.
MDR Article 87 Reporting Timelines
- • 2 days: Serious public health threat
- • 10 days: Death or unanticipated serious deterioration
- • 15 days: Other serious incidents
- • Immediately: Statistically significant increase in incidents
UDI Structure Validator
Parse and validate UDI (Unique Device Identifier) format. Supports GS1, HIBCC, ICCBBA, and IFA formats.
UDI Components
- • UDI-DI: Device Identifier (identifies device model)
- • UDI-PI: Production Identifier (lot, serial, expiry, manufacturing date)
- • Issuing Agencies: GS1, HIBCC, ICCBBA, IFA