A new expert subgroup of the MDCG was established to cover Annex XVI products; therefore…
Clinical Evaluation Report: New MDR implementation tool
The results of clinical evaluation and clinical evidence on which it is based shall be…
MDCG Guidance on Basic UDI-DI
Updated guidance was just published by the MDCG to better clarify the notion of Basic…
Official MDR & IVDR Corrigendum published!
On May 3rd 2019, the Corrigendum of both Regulations was published in the Official Journal…