MDCG publishes new guidance documents on the MDR and IVDR

Article summary

The Medical Device Coordination Group (MDCG) has published new guidance documents on Regulation (EU) 2017/745 on medical devices (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)). The first document presents questions and answers on the Unique Device Identification (UDI) system under the MDR and IVDR and seeks to provide further detail to operators on the application and implementation of the UDI requirements. The second document provides guidance on the applicability of IVDR requirements to ‘legacy’ and ‘old’ devices, including a non-exhaustive table illustrating whether IVDR requirements apply or do not apply to legacy devices. The third document provides a template for manufacturers who are required under the IVDR to draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP must be validated by a notified body and be made publicly available via the European...