Hi everybody. This is Domenico Yannone, your host today, and you are listening to MetteConner, the official METEC Europe podcast.

Today with me we have Petra Zulner, with director MDR and IVDR at

Metac Europe. Welcome, Petro. Thank you, Domenico. Pleasure to be here. Today, we're going to discuss

the results of the recent survey released by Mettaic Europe about the impact of the IVD regulations. But before diving into the

results of the survey, Petra, can you please give us an overview on what the in vitro diagnostic

regulation is? Sure, de Medico. So as you mentioned, the IVD regulation sets out rules

to ensure safety and performance of IVD medical tests, taking as its basis

a high level of protection of health for patients and users. Today we are in a transition period

to the new rules. Most IVD medical tests have a deadline to be certified under the new regulation

by either May 2025, May 26, or May 27, depending on their level of risk.

So tests with a higher risk have to be certified sooner than tests with the lower risk class.

Until these deadlines, manufacturers may choose to continue to comply with the previous law, the IVD directive,

or to opt for compliance earlier on with the regulation.

All IVD medical tests, which are today moving under the new regulation, will need at least

one certificate issued by a designated auditing organization known as a Notify Body.

Under the previous EU law for IVDs, only 8% of products required

notified body certificates. But under the new regulation, it's important to understand that 78%

of products will need a certificate from a notified body. This means that at least 35,000 IVDs

will be covered by Notify Bodies for the very first time. Thank you for this

useful overview. Now let's have a closer look at the survey itself. What is the scope of this exercise?

Sure. So we launched our first survey assessing the state of the transition to the new IVD regulation in July

2021. And then we had a second survey in October 2022. And as you know, we recently published our

...