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Hello experts!
Let me make a question concerning the general obligations of importers and distributors under the EU MDR 2017/745: how do you interpret Articles 13.2 and 14.2?
Articles 13.2 states that "
In order to place a device on the market, importers shall verify...": it seems to suggest that all checks by the EU importer shall be conducted at the moment of inbound acceptance
only the first time the EU importer receives the medical device. Or those checks shall be conducted every time the importer receives it?
Article 14.2 declares that "
When making a device available on the market, distributors shall...": it seems to suggest that distributors shall conduct a sample verification on devices
before the shipment to the customer.
What do you think? What is the difference between the moment when importers and distributors shall conduct the checks?
Thanks in advance to anyone could provide me with a useful and clear reply!