Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system, conformity assessments, and the role of notified bodies. This was followed by part 2, where we discussed clinical evidence, post-market surveillance, and transition periods. We will now focus specifically on requirements for medical device software (MDSW) as an IVD (IVD-MDSW) and the delimitation between the application of the EU Medical Device Regulation (EU) 2017/745 (MDR) and application of the IVDR to a software device.
Read the full blog post.