Welcome to MetTech on Air, your window into the world of medical technologies.

This is a podcast by MetTech Europe, which is the European Trade Association for the

Medical Technologies industry. My name is Dominica Suhojanova.

I am a communications manager at MetTech Europe, and I'm very happy to be hosting today's podcast.

In this episode, we are going to take a closer look at a very important piece of legislation.

The European Commission is planning to publish a reform proposal for the EU regulatory framework

for medical technologies.

This is a moment that we have been advocating for a very long time, and this is going to change

our industry for the next years.

To dive deeper into this topic, today we are speaking with Petra Zellner, who is responsible for

regulatory affairs for medical technologies and in vitro diagnostics at MetTech Europe.

Petra, welcome to the podcast. We are very happy to have you with us today.

Thank you, Domenica. It's a pleasure to be here with you.

And before we start with the technical aspects, could you explain to us why this reform proposal is so important?

And what is at stake if Europe doesn't get it right? Sure. So first of all, I am delighted that a European proposal to reform our IVD and medical devices regulations is coming very soon, probably by the end of this year.

Our industry has really high hopes from it.

In particular, we want to see a regulatory system that really works, that's efficient, that's

predictable, and is also well governed.

Thinking about what's at stake, I think this reform proposal is really the opportunity

for the European Commission to make sure that

our regulations finally deliver on what they're supposed to deliver, which is a full range

of safe and performing medical technologies which will reach patients in a timely matter.

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