Supply chain and economic operator regulation under the MDR and IVDR

Credits: Bassil Akra of TÜV SÜD One of the interesting features of the new MDR and IVDR is the new chapter on economic operators (chapter II), which implements a completely new (to the medical devices industry at least) regime of supply chain regulation and related aspects. The new supply chain regime was on the horizon for a long time because it was conceived in 2008 and has in the mean time been implemented for a number of product groups covered by EU legislation. It has now, totally expectedly, found i [...] « Read the rest of this article on medicaldeviceslegal »