ISO 13485 & EU MDR / ISO 13485 for trading of medical devices
Dears, I'm working currently in a company that export and import some medical devices (without manufacturing ), is it eligible to be certified with ISO 13485?
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If you only make export and import of medical devices, It is not a regulatory requirement to be ISO 13485 certified. What is expected from the importer and distributor of medical devices is stated in Article 13 and Article 14.
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