The MDR refers to the Medical Device Regulation, a set of rules and standards established by the European Union to ensure the safety and efficacy of medical devices sold in the EU. This regulation replaced the previous Medical Device Directive (MDD) and imposes stricter requirements for the design, manufacturing, and marketing of medical devices.
To comply with the MDR, medical device companies need to ensure that their products meet the new regulatory requirements, as well as ensure ongoing compliance.
How does content management impact MDR?
Content management impacts MDR compliance by ensuring that all relevant documentation, including labelling and instructions for use, are accurate, up-to-date, and easily accessible to regulators, notified bodies, and end-users.
Implementing structured content and managing it in a Component Content Management System (CCMS) can help with compliance with MDR by enabling companies to efficiently create, review, and update content in compliance with the new regulations.