medicaldeviceslegal

“E” is for economic operator – you know: the MAID

In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo calls them in an interesting analysis of the IVD regulation proposal: the MAID (manufacturer, authorized representative, importer, and distributor). Both the IVD and medical devices regulation lumps all of these together in a single section of the proposal, along the methodology of Decision 786/2008 on a common framework for the [...] « Read the rest of this article on medicaldeviceslegal »