Welcome to MedTech on Air, a podcast by MedTech Europe.

MedTech on Air is your window into the world of medical technologies.

Listen in as we interview industry experts and shine a light on our sector's valuable contributions to improve

health care systems and patients' lives. My name is Estefania Cordero, communications manager,

and I'm the host of the MedTech on Air podcast. Petra Zolnner, director of the MedTech Europe Regulatory Affairs

Department, is joining us in today's podcast to discuss our vision for the future of the European

regulations on medical devices and in vitro diagnostics, in short, the MDR and IVDR, and how

these can bring innovation and improve patient outcomes in Europe. Petra,

welcome to MedTech on Air. We're so pleased to have you in the pod today. Thank you, Estafania.

I'm very happy to join and looking forward to our chat this morning. Petra, MedTech Europe has been

calling for a reform of the European regulations that govern the medical technology sector, and I'd like to

talk to you about that today. Before we dive into why we're calling for reform, though, can you,

in a few words, tell us about what our sector's regulations are? Sure. So our sector is regulated by

two European laws. So on the one hand, you have the medical devices

regulation covering medical devices. And on the other hand, you have the IVD regulation covering

in vitro diagnostic medical tests. These regulations have been around for almost seven years now.

And they're aimed at providing a high level of safety and health while supporting innovation

and ensuring a smooth functioning both of the EU's internal market and the great many

small and medium-sized enterprises that are active in the sector.

So the regulations were published in 2017, and there are already discussions about reforming

them. Why is that? So in the almost seven years

since the regulations were published, our industry has experienced significant challenges, both in the

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