> regulation_(eu)_2017/746
Regulation (EU) 2017/746
European In Vitro Diagnostic Medical Devices Regulation (EU IVDR)
Regulation (EU) 2017/746 (EU IVDR) establishes regulatory requirements for in vitro diagnostic devices and specimen-analysis software. It replaced the previous IVD directive with a risk-based classification (Class A to D), subjecting over 80% of IVD software to independent notified body conformity assessments, analytical performance validation, and post-market performance follow-up (PMPF).
Scope & Applicability
Applies to reagents, instruments, apparatus, and software intended for the in vitro examination of human specimens (blood, tissue, genetics).
Non-Coverage Boundaries
Does not apply to general medical devices acting directly on the human body (governed by MDR).
Key Clauses & Control Requirements
Risk Classification (Classes A through D)
Class D for high-risk blood screening/infectious diseases; Class C for oncology and genetic diagnostic algorithms; Class B for standard tests.
Required Regulatory & Audit Evidence Artifacts
- [✓]Performance Evaluation Report (PER) covering scientific validity and analytical performance
- [✓]Post-Market Performance Follow-up (PMPF) Plan and Reports
- [✓]Notified Body IVDR CE Certificate
“If your software computes biomarkers or genetic risk scores from patient blood or tissue samples, it is an IVD under European law and requires rigorous analytical validation.”
Cross-Surface Ecosystem Relationships
Frequently Asked Questions
Does IVDR apply to software-only algorithms?
Yes. Algorithms that analyze lab assay data, genomic sequencing data, or specimen images to provide diagnostic outputs are regulated IVD software.