Introduction to Medical Device Regulations - MDR
For 30 years medical devices have been governed by the Medical Device Directive (MDD) implemented in EU/EEA in 1993, and there have been quite a few developments in the field of medical devices since then. For instance, apps used as stand-alone products for different medical purposes have become a reality. The general population has become older, patients are more used to finding medical information on the internet, and the beauty industry uses more advanced and invasive techniques than before. These changes, and more, have prompted an update of the control of medical devices for some time. Eventually, the new Medical Device Regulations (MDR) were developed and came into force on May 26, 2021. From this date, all new medical devices and the manufacturer’s quality management system must comply with the MDR. Implementation deadlines for existing devices are dependent on classification and expiry of existing MDD certificates.