Faster Market Entry Through Integrated IVDR and WHO Strategy

Challenge

The client aimed to launch a Class D diagnostic test-suitable for professional, near-patient, and self-testing - in the European market under IVDR while simultaneously pursuing WHO prequalification.

Navigating these two regulatory frameworks posed significant challenges around complexity, timelines, and sample volume requirements.

Approach

To tackle this, we designed an integrated strategy that combined IVDR and WHO requirements to avoid duplication and minimize the total sample size.

Our team managed four tailored studies:

• A combined clinical performance study
• Near-patient and self-test studies for IVDR
• Separate self-test study for WHO prequalification.

Serving as the client’s legal representative, we facilitated smooth ethical and regulatory approvals. From study setup to site coordination and ongoing communication with authorities, we provided full project management to keep everything on track.

Result

This first-time-right strategy enabled the client to meet both IVDR and WHO requirements simultaneously, reducing sample needs and accelerating timelines.

The efficient approach saved costs and cut time to market, earning praise for our expertise and practical solutions. This success also paved the way for ongoing collaboration on multiple additional products.