Medical device manufacturers must provide regulatory teams with the tools and resources to ensure compliant interactions with their supply chain partners.
Tag archives: #importers
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”.