Challenge: A genomics laboratory sought to CE mark their NGS exome sequencing panel targeting over 4,000 genes under IVDR-an unprecedented scale for IVDR certification.

Solution: MDx implemented a comprehensive regulatory strategy including:

• Complete technical documentation for the NGS workflow
• Validation of the bioinformatics pipeline as a medical device
• Implementation of ISO 13485 QMS tailored to NGS operations
• Expert management of the Notified Body submission process

Result: CE mark granted in just 16 months, enabling the client to become one of the first laboratories globally to certify such a comprehensive gene panel under IVDR.