As one of the first medical device manufacturers
The original start date for the scope of the new Medical Device Regulation (MDR) EU 2017/745 was May 26, 2020. Due to the Corona crisis, the new Medical Device Regulation was postponed by a whole year, as a changeover even under regular operation would have presented many medical technology companies with major challenges, which they did not want to be additionally burdened with during the exceptional situation caused by Covid-19.
mbits had already converted its quality management to MDR before the Corona crisis. The just released new version of our app mRay 6.0 has already been developed according to MDR guidelines without exception.
The changeover requires some fundamental adjustments to existing workflows - a major challenge. The immediate assistance program of the Health Industry BW works with companies to develop group-specific content and make it available.