What is IVD-R?

IVD-R is the European law defining the requirements to obtain a CE certificate for in-vitro diagnostics devices. It's a real tsunami that will affect our industry profoundly.

Which impact will it have on laboratories and distributors?

The IVD-R will have some positive effects:

• Requiring more robust clinical evidence for the manufacturers claims about their products
• More control and surveillance of the products and manufacturers
• Elimination of free-riders (companies that falsely claim to have CE quality/products)

However there will also be some very significant negative effects:

• Less innovation
• Less diversity or choice
• Less manufacturers
• More costs

Which questions should you ask to avoid surprises?

To ensure the continuity of your clinical operations, it's best to check if your current suppliers are future-ready.

In this video, you will find the the five most important questions you must ask your IVD manufacturer.