EU In Vitro Diagnostic Regulation
IVDR has changed
In Vitro device manufacturers of many products will now be required to provide documentation for regulatory approval through EU Notified Bodies and gain CE Mark certification.
Fang Consulting is prepared to provide regulatory guidance and consulting services to meet the new EU IVDR requirements. We will help you gain understanding of the new regulations that may include your products. We are familiar with the new requirements for both technical documentation and post market surveillance and will help you gain regulatory compliance.
*IVDR compliance requirements take effect on May 26, 2022.
- Device Classification Review
- New rule-based risk classification compared to current IVDD list-based classification
- New/updated required documentation
- Performance evaluation plans and reports
- Post-market surveillance plans and reports
Technical documentation gap assessment
- IVDR provides more specifics of what needs to be included in Technical Documentation
QMS gap assessment
- IVDR provides more specifics of what needs to be included in a manufacturer’s QMS
Notified Body Submissions / Reviews
- All devices require Technical Documentation, UDI & post-market surveillance
- Notified Body conformity assessments required for most classes of devices