< 1 min reading time Can you explain what Article 22: System and procedure packs of EU MDR means? What, exactly, do we do to comply with this article? Marked as spam |
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Private answer Michelle Lott , RAC Hi Saurabh, Michelle Marked as spam | |
Private answer Kristin Gatter Hi Michelle, My company manufacturers a class IIA device that requires an insertion pack (class IIb) that is provided as a sterilized kit. The kit that we provide includes a sheath that is manufactured by a third party, has been verified and validated to work with our device, and bears its own CE mark. Are we required to provide a statement regarding the sheath to be compliant with Art. 22? If yes, how much information is required to be provided in that statement? Marked as spam |
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