Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to establish national language requirements for makers of device companion materials. …
In August 2023, the COFEPRIS, the Mexican Regulatory body in charge of the regulation of Medical Devices, updated the Guidance Document by defining types and impact of product or organizational ch…
We’re taught from an early age that hard work is key for success. What we’re not taught is that hard work comes in two equally important forms: effort to perform and effort to improve.
Team’s l…
Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments (MR…
MDR 2017/745 and IVDR 2017/746 EU laws establish an EU identification system for medical devices based on a Unique Device Identifier (UDI) and oblige medical device manufacturers to disclose the U…
