In this episode, we have an exciting deep dive as we unpack the results of the regulatory survey report with Petra Zulner, who is director of IVDR and MDR at MetTech Europe.

She's going to guide us through the key findings of the results.

My name is Stefania Cordero, and I'm the host of this new season of MetTech on Air, your window into the world of medical results. My name is Stefania Cordero and I'm the host of this new season of MetTech

on Air, your window into the world of medical technologies. Welcome to the podcast, Petra. It's so nice to have

you. Thank you, Stephanie. It's great to be here to talk to you about our latest survey results.

Before we dive into the results of the survey, let's start with a bit of background for our listeners so that we can really set the stage.

Can you give us some background on these regulations, the IVDR and MDR, what really led us up to the launch of the survey?

Sure. So in Europe, we have two regulations, one for medical devices and one for

in vitro diagnostic medical devices. MediC Europe has been supportive of the regulations and their

objectives since day one. I think it's important for listeners to know that at the moment medical

technologies are still very much in

transition to the two European regulations. It's been almost eight years since the regulations

entered into force. And since that time, we've seen two extensions given to each regulation

for devices in the market at the moment to transition

to the new rules because there have been so many challenges with the implementation of those

rules. This survey takes into account those massive challenges and looks into what has the

impact been of the regulations on key areas like cost for manufacturers,

timelines to transition, and also the impact on innovation activities.

That background is really helpful, Petra. Thank you so much.

The findings from the survey have certainly generated quite a bit of buzz in the media and also

with policymakers.

Tell us a bit more.

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