EU MDR Technical Documentation: Purpose and Contents
EU MDR technical documentation is the backbone of compliance for medical devices in Europe. It must comprehensively demonstrate conformity with EU medical device regulations and its documentation requirements. The MDR technical documentation must be prepared before...
EU MDR Rule 11 Classification for SaMD & CE Mark Process
In this blog, we have explained the EU MDR Rule 11 classification for SaMD. Additionally, we have detailed the CE mark certification process for SaMD. What is SaMD? Software as a Medical Device (SaMD) refers to standalone software that has a medical purpose on its...
CE Marking of Digital Health Technologies: EU MDR Guidelines
Digital health technology is the integration of digital tools into healthcare to improve prevention, diagnosis, monitoring, and treatment. CE marking of digital health technologies is mandatory under the EU Medical Device Regulation (MDR). It ensures that software,...