"Placing on the market" & "putting into service"- one time regulatory event or Continual supply event?

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nz1nz2

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Dear Forum members,
It seems i have a different point of view for the three definitions which i'm having difficulty to explain to my colleauges. I would be delighthed to hear your thoughts on this topic.
The use of the word "first" both in the "placeing on the market" and "put into service" made me think on this two events as regulatory one-time events, i.e. happen once the first time a device is made available in the EU and not each time a batch/lot is made availabe. for example if a manufacturer first introduce a new medial device in the EU it is considered to place the product to the EU market (regulatory event). All other supplies of this product to the EU is considered to fall under "making the product availabe" (supply events). The only next time this manufacturer will "place" this device on the market again is if there's a significant change to the device which will make the company to "place" the device again to the market. This fits well with the reqquierment that no major change can be done to an already "place on the market" device in order for it to be "available on the market" during the transition period.

If i use the "make available" definition inside the "place on the market" definition it would be:
Placeing on the market: Any first supply of a device, for distribution, consumption or use on the union market in the course of commercial activity...

Thank you in advance for any comment.
 
GAGEpack - Gage & Calibration Management
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