Hello and welcome to the first episode of METEC on Air.

I'm your host, Gianluca Painetti, and I am joined today by METEC Europe's Director for Regulations and Industrial Policy, Oliver Bissatza.

Welcome, Oliver. Thank you for being here.

Thanks, John Luca. Happy to be here.

So today, today we're going to talk about EU medical technology regulations, specifically new regulations, and we're going to focus on

the C-marking process for medical technologies.

But before we actually dive into the topic, why don't you tell our listeners a little bit

about yourself and what actually a director for regulations and industrial policy

does here at METIC Europe?

Yeah, sure.

So I'm Oliver.

I've been here about three years and I head up the association's regulatory team.

The regulatory team is here to support METEC Europe members in their efforts to comply with EU legislation, especially

EU legislation on products. Our overwhelming focus right now and has been for a while is the new

EU regulations on in vitro diagnostics and on medical devices, but we also engage on other EU laws that are relevant for

our members, such as rules on environmental protection. Our support takes two main forms. One,

we give members a home where they can come together to discuss these regulations and brainstorm

solutions, which often materialize

in the form of common industry position statements, guidance documents, and so on. So there's a strong

internal piece. But we also represent the industry externally. You know, we take our members' positions

and perspectives to the EU institutions here in Brussels and also to other external stakeholders interested in MedTech.

So what do I do? I spend a lot of time in the office helping members find good ways forward, but I also spend a lot of time outside the office representing the members and ensuring their voices heard

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