WHO AM I? IMPORTER? MANUFACTURER? DISTRIBUTOR? Article 13 of the MDR brings light into the dark regarding importers -- MEDICA - World Forum for Medicine

04.11.2020

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WHO AM I? IMPORTER? MANUFACTURER? DISTRIBUTOR? Article 13 of the MDR brings light into the dark regarding importers

For importers of medical devices the following instructions apply: Check. Report. Cooperate. And be jointly and severally liable when the going gets tough, one might add. But enough of the guessing game about who will take over the responsibilities of the distributor, manufacturer and/or importer. seleon’s list details and describes tasks and consequences for the species mentioned.
The Regulatory Affairs Blog of seleon gets down to business!

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