Welcome back everyone to episode 7 of MedTech on Air.

I'm your new host, Caroline Moulin, and I'm joined today by MedTech Europe Director General

Industrial Policy, Oliver Bissata.

For those who just starting following us, Oliver was a guest during the first episode of

MetTech on air, which you can listen to on our usual channels.

Welcome, Oliver. It's a pleasure to have you back on MetTech on Air.

Thanks, Caroline. It's a pleasure to be back.

So today we're going to talk specifically about the new in vitro diagnostic regulation,

often shorten and called the IVDR. The new IVDR will enter into full application on 26th of May 2022.

It will bring many benefits to the healthcare sector, but some challenges will remain, and we will

elaborate on this in a few minutes. So maybe before we dive into a topic, Oliver, could you tell us

a little bit about yourself, you roll at MedTech Europe, and your experience on IVD regulation?

Yes, sure. So as the Director General Industrial Policies, my department takes care of European Union legislation that is relevant for making tests and other medical technologies available to patients in Europe.

So it's a wide variety of legislation, including the IVDR, the medical devices legislation,

legislation on health technology assessment, and on sustainability topics like environmental

protection too.

Thank you, Oliver, for this introduction.

So as we said before, the new IVDR will come into force in May 2022. Thank you, Oliver, for this introduction. So as we said before, the new IVDR will come into

force in May 2022. Maybe could you briefly introduce this regulation and explain why it is

important for the medical and diagnostic sector? Of course. So the IVDR is the new European legislation

regulating the quality, safety, and performance of medical

tests that are placed on the European market. These tests, or IVDs, are absolutely critical for making

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