EBMCI

Resources Center

Stay informed with the latest regulatory insights, industry updates, and expert resources

Government Shutdown Update – Impact on FDA Establishment Registration and Submissions
As you may …
read more
Elite BioMedical Corporation, Inc. at MEDICA 2025 in Düsseldorf, Germany
We are exci…
read more
Taiwan AI Smart Health Showcase Center – Phoenix, AZ
Elite BioMe…
read more
FDA FY2026 MDUFA User Fee(s) & Establishment Registration Fee
The followi…
read more
Navigating EU IVDR

Comprehensive guide to understanding and implementing the In Vitro Diagnostic Regulation requirements.

AI in Medical Device Compliance

Explore how artificial intelligence is transforming regulatory documentation and quality management.

Navigating EU IVDR

Comprehensive guide to understanding and implementing the In Vitro Diagnostic Regulation requirements.

What are the key timelines for EU IVDR compliance?

The European In Vitro Diagnostic Regulation (IVDR) requires full compliance by May 26, 2025. Manufacturers need to ensure their technical documentation, clinical evidence, and quality management systems meet the new stringent requirements.

The European In Vitro Diagnostic Regulation (IVDR) requires full compliance by May 26, 2025. Manufacturers need to ensure their technical documentation, clinical evidence, and quality management systems meet the new stringent requirements.

The European In Vitro Diagnostic Regulation (IVDR) requires full compliance by May 26, 2025. Manufacturers need to ensure their technical documentation, clinical evidence, and quality management systems meet the new stringent requirements.

The European In Vitro Diagnostic Regulation (IVDR) requires full compliance by May 26, 2025. Manufacturers need to ensure their technical documentation, clinical evidence, and quality management systems meet the new stringent requirements.