Certifications

We have good news once again! We continue certifying DIMA products under the MDR regulation. This year, two products have obtained certification: one for male urinary incontinence (Male Remeex System) and another for vaginal prolapse (Surelift Anchorsure). What is the MDR? The Medical Device Regulation (EU) 2017/745 is the (relatively) new European regulation governing medical devices. It defines the requirements and obligations that all manufacturers and distributors must co

We have great news to share! After years of hard work, we have successfully obtained MDR approval for two of our female urinary incontinence product families: Female Remeex System and Contasure Needleless. What is the MDR? The MDR is the new European Regulation on medical devices that defines the requirements and obligations that all manufacturers and distributors must comply with in order to market a medical device in the European market. In addition to incorporating the pre