Join our upcoming Platomics webinar as we discuss one of the most persistent misconceptions in diagnostics: the belief that ISO 15189 accreditation alone makes a laboratory compliant for in-house devices under the IVDR. 

We’ll break down the overlap, expose the gaps, and show what Article 5(5) really expects from diagnostic laboratories. Whether your lab builds, modifies, or adapts its own tests, this session will help you understand the In-House IVD trap and how to avoid it with structure, transparency, and smart digital support. 

What we’ll cover:

• Why ISO 15189 is required – but NOT sufficient for IVDR Article 5(5)

• ISO 15189-accredited and still not compliant: How laboratories unintentionally expose themselves to regulatory and clinical risk.

• Hard facts: What are the differences between ISO15189 and IVDR Article 5(5)

• Country-specific interpretations and what they mean for your lab

• Real-world scenarios: When does ISO 15189 help, and when does IVDR take over?

• A pragmatic pathway to compliance: how labs can meet IVDR requirements without over-engineering processes.

• Leveraging Platomics digital solutions for structured, efficient IVDR documentation to cover IVDR requirements for full compliance 

Webinar details:

📅 Date: Tue 09.12.2025
🕒 Time: 13:00 - 14:00 (CET/UTC+1)

Let’s shape a safer, smarter laboratory together.
Save your seat today!