In December of last year, the European Commission published the long-awaited proposal to amend the IVDR - a development with potentially far-reaching implications for diagnostic laboratories across Europe.

The proposed amendments also directly affect Article 5(5) and, with it, the regulatory framework for in-house IVDs. But what does the proposal actually change? What is realistic to expect - and what is not? And most importantly: what could this mean in practice for laboratories that develop and use in-house tests?

In this expert discussion with Erik Vollebregt (AXON Lawyers), we will take an in-depth look at the proposal, unpack its regulatory intent, and discuss its potential practical impact on laboratories operating under Article 5(5) IVDR.

What we’ll cover:

• Article 5(5) IVDR today - current status and core requirements

• The new IVDR amendment proposal - what can we expect from an in-house IVD perspective?

• Key elements of the proposal - what laboratories need to know

• Deep dive: proposed changes to Article 5(5) IVDR

• Practical implications - what could this mean for laboratories in real life?

• Expectations vs. reality - how can laboratories prepare strategically?

• Additional insights beyond article 5(5) IVDR - What else does the proposal have in store for us?

• Live Q&A with the experts 

Webinar details:

📅 Date: Thu 19.02.2026
🕒 Time: 16:00 - 17:00 (CET/UTC+1)

Let’s shape a safer, smarter laboratory together.
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