Challenge: A digital health company sought CE marking under IVDR for their AI-powered diagnostic algorithm, with significant classification questions and limited clinical evidence.

Solution: MDx implemented a comprehensive regulatory strategy including:

• Software classification guidance under IVDR rules
• AI algorithm validation protocol development
• Clinical performance study design specific to the algorithm’s diagnostic claims
• Complete technical documentation aligned with IVDR Annex II and IEC 62304

Result: Successful CE marking achieved under IVDR with minimal deficiencies, establishing a regulatory precedent for similar AI-based diagnostics.