Upcoming webinar: what IVDR Article 5(5) means for your lab

The EU In Vitro Diagnostic Regulation (IVDR) is transforming how clinical laboratories develop, validate, and justify their in-house tests. With Article 5(5) now in effect, in-house IVDs are officially within the scope of regulatory requirements. 

Join our upcoming webinar called IVDR & In-house IVDs: What IVDR Article 5(5) means for your lab. This informative webinar will explore:

• The scope and impact of IVDR and Article 5(5)
• The current status of IVDR implementation in 2025
• What Article 5(5) means in practice for clinical laboratories 

Practical guidance to help you stay compliant

Whether your lab is already working under Article 5(5), evaluating tests, or preparing for transition, this free online webinar will offer practical guidance to help you stay compliant.

📅 Date & time: Thursday, December 4^th, 11.00-12.00  EET (UTC +2:00)
📍 Location: Online
🎯 Target group: Clinical laboratory professionals, regulatory teams, and quality managers

Do you need support with your in-house IVDs? 

We support IVD manufacturers in navigating the IVDR landscape with services tailored to accelerate readiness:

• Classification
• QMS compliance
• Performance evaluation
• Post-market surveillance
• Gap analysis & auditing
• Technical documentation
• Training

Let’s work together to ensure your products stay on the market — and ahead of the curve. Contact us so we can discuss your specific needs.