IVDR

The In Vitro Diagnostic Regulation (IVDR) is the European Union regulation that replaced the previous In Vitro Diagnostic Directive (IVDD) on May 26, 2022. It establishes stricter requirements for IVD devices placed on the EU market.

Key features of IVDR:
- Regulation EU 2017/746 adopted in April 2017
- Replaced IVDD (98/79/EC) on May 26, 2022
- Risk-based classification system: Class A, B, C, D (D highest risk)
- Mandatory EUDAMED registration for all devices
- Stricter clinical evidence and performance evaluation requirements

IVDR classification system:
- Class A: Lowest risk (e.g., specimen receptacles)
- Class B: Moderate risk (e.g., pregnancy tests)
- Class C: High risk (e.g., HIV tests)
- Class D: Highest risk (e.g., blood screening, companion diagnostics)

Notified Body requirements:
- Class B, C, D require Notified Body conformity assessment
- Class A can self-certify (sterile devices need NB involvement)
- Stricter designation criteria for Notified Bodies
- Capacity constraints led to extended transition periods

Transition timelines:
- May 26, 2017: IVDR published
- May 26, 2022: Date of application (IVDD ceased)
- May 26, 2025: Extended deadline for Class D devices
- May 26, 2027: Extended deadline for Class A-C devices
- May 26, 2028: Final deadline for legacy devices

Key changes from IVDD:
- Performance evaluation requirements strengthened
- Post-market surveillance more rigorous
- Unique Device Identification (UDI) mandatory
- Economic operators' responsibilities clarified
- Person responsible for regulatory compliance (PRRC) required

EUDAMED database:
All IVDs must be registered in the European Database on Medical Devices (EUDAMED) with detailed technical documentation.