What means "Placing on the market"? (CE mark Medical Device)

What does it mean to place a product on the market for a Medical Device?
[Download Powerpoint Slides - Link below]

I try to answer this question as it's not easy to understand the difference when a product is still under the manufacturing control and the product is under the distributor control. This is a critical question for the Medical Device Industry.

I use the Medical Device Regulation EU MDR 2017/745 and the blue guide as a reference to provide you the answer to it.

There are 3 definitions that are important for a better understanding:
Placing on the market
Making available on the market
Putting into service

I show you what is the connection between those 3 definitions.

Maybe you ask yourself why is this so important. On the new MDR 2017/745 on Article 120 paragraph 4, there is a sentence saying:

"Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, and devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025."

So for your business survival, this definition is key. If you don't place your product on the market before May 26th, 2020, then they can be lost and the only choice you'll have will be to scrap them.

Let me know in the comment if this is really helping you.

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Links from the Video

Blog Post: https://easymedicaldevice.com/mdr-tra...
EU MDR 2017/745 & Blue Guide (EUROPE): https://easymedicaldevice.com/resourc...
Presentation slides: https://mailchi.mp/f29ec4a61e77/placi...
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