Homonym: MDR (Laugh)
MDR stands for "Medical Device Regulation," which is a set of rules established by the European Union to ensure the safety and effectiveness of medical devices. These regulations apply to a wide range of products, including surgical instruments, diagnostic equipment, and implantable devices. The MDR aims to protect patients and users by requiring thorough assessments and compliance with strict standards before devices can be marketed.
The MDR came into effect in May 2021, replacing the previous Medical Device Directive (MDD). It introduces more rigorous requirements for clinical evaluations, post-market surveillance, and transparency in the approval process. Manufacturers must demonstrate that their devices meet these standards to gain access to the European market.