CE mark transition and new regulations

#1
My company, a CMO to a larger company as well as having our own portfolio, is transitioning from UL to PCBC (Poland) CE certification. My manager is asking me to research vigilance reporting and FSCA's in Poland due to this, however, our products (where we own the design) are not sold in Poland, only Germany, China, and the US. Most of the Polish regulations explicitly mention that deaths/AEs/malfunctions that could lead to death or AE that happen within the territory of Poland should be reported to the Office of the President.

I'm fairly new to the industry, and am trying to connect the dots and determine our reporting requirements. A product manufactured in the US, sold to Germany, with a CE mark from a Polish Notified Body.... Does this mean all incidences that happen in Germany must be reported to Poland?

Our EU classification is 2b.

Thanks in advance for any input that may help me navigate this.
 
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