Welcome to a new episode of METECONER. This is Domenico Yannone from the Metacurop Studio.

And with me today have the pleasure to invite Merlin

Richel who is senior manager medical devices at Metac Europe. Welcome Merlin.

Charles Domenico, thank you for the invitation.

Merlin, we know that before being placed into the European market, medical devices go through a really specific process.

Can you give us a bit of overview on the history of medical regulations in Europe and on what is

the current status on it?

Thanks to Mniko.

So, yeah, this short answer is since 2017.

It's regulated by a regulation, the so-called MDR.

And if you're asking for a longer answer, then I would say that prior to the MDR devices were regulated under two directives. The medical devices directive, more commonly

known as the MDD, and the active implantable medical device directive, the AIMD. And these

directives were both published in the 1990s and they regulated the MetTech sector for over 20 years.

But over these 20 years, technologies evolved tremendously.

I'm thinking here of artificial intelligence, software development, cybersecurity,

which was not in the focus before.

And stakeholders also ask for more transparency

and traceability requirements, which were not billed in the directives originally.

So the directives were replaced by a regulation, the MDR, which is directly transposed

into national law.

In other words, without room for interpretation, that's really the spirit,

and which de facto merged the MDD and the AMD into one piece of single legislation.

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