The move from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) is one of the most daunting challenges facing medical device manufacturers today. In this video, Linda Chatwin, Esq., RAC from UL explains what companies can do to prepare for the transition to the more stringent requirements of MDR.
In most cases, MDR asks more of medical device manufacturers. Companies will have to perform gap assessments to anticipate where they fall short before the MDR deadlines. However, it’s not just manufacturers that will have to adapt, it’s also the Notified Bodies (NBs) that they work with. All NBs will have to recertify and now is the time to determine if your current NB is adaptable enough to meet new requirements.
A major demand on medical device manufacturers will be the use of unique device identifiers (UDIs) and an associated database. The European Database for Medical Devices (EUDAMED) will contain every device on the market and manufacturers are required to report serious incidents and field safety corrective actions to the database.
Watch the video in its entirety to learn more about requirements for manufacturers, changes to NBs, and how CE marks work under the new rule.