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Jul 10, 2025 11:21 am
I am looking to establish if there are any restrictions on where a PRRC can be located geographically? We are the legal manufacturer based in the EU with manufacturing sites based in Asia, supplying medical devices into the EU. Is it acceptable for a PRRC to be based in Asia or anywhere else in the world? Interested to know if anyone else has setup with this or similar arrangements?
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Jul 11, 2025 9:42 am
A PRRC can technically be based in Asia or elsewhere if they are tied to the EU legal manufacturer and can demonstrate availability and compliance. However, due to regulatory expectations and practical considerations, many companies choose to base their PRRC within the EU.