medicaldeviceslegal

The EU Court’s Schrems II judgement – urgent revisiting of international personal data transfer mechanisms required

Wasn’t the MDR about More Data Required, and the same for the IVDR? Aren’t more and more devices running software that processes patient and user data? Isn’t the medical devices industry a very international business? Indeed – so the ability for companies working with the MDR and IVDR to transfer personal data internationally for all kinds of purposes MDR and IVDR related such clinical investigations, PMCF/PMPF, usability testing, trouble shooting / support, registries, communication [...] « Read the rest of this article on medicaldeviceslegal »