What is MDD/MDR?

MDD/MDR typically refers to Medical Device Directives/Regulations. The Medical Device Directive (MDD) was a European Union directive that set the regulatory requirements for medical devices sold in the EU. It has been superseded by the Medical Device Regulation (MDR), which introduces stricter requirements for clinical evidence, post-market surveillance, and traceability of medical devices. The MDR aims to improve patient safety and ensure a high level of health protection. The terms are used to describe the legal framework governing medical device development, manufacturing, and distribution within the European market.