Are your EU distributors ready for 26 May 2021??

European Regulatory requirements1DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether: the device has the (CE) mark and an EU Declaration of Conformity has been issued; the importer’s name is affixed on each device or is …

Article 16 and Then Some

Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day to day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.