The MDR 2017/745, as well as the IVDR 2017/746, define and demand to use of harmonized standards or other standards for purposes of maintaining the state of the art of the product technology and development. This is especially cumbersome in the medical device industry as many standards exist, standards undergo a 5-year lifecycle and new standards evolve continuously. We monitor and report on any updates and changes for regulations, standards, and guidelines. The report is sent monthly to your email inbox and tailored to the standards, regulations, and guidelines of your interest from the current monitoring list you have provided and our monitored sources.
Updates to the monitored sources will be communicated to you to update the monitoring list at no additional cost.