MDCG - Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation 2017/745 and In-vitro Diagnostic Regulation 2017/746. The MDCG takes part

Medical Device definition has been changed with the new EU MDR 2017/745 and the impact of this change over manufacturers of "borderline" devices is huge. With QualityMedDev websites we have

We have already been discussing about the requirements associated to legacy devices, mentioning as well the existence of the Article 120 MDR, which basically regulates the transition period between the

The free sale certificate is an essential document to expert medical devices. These are certificates that are aiming at facilitating the export of medical device and in-vitro diagnostic devices outside

The understanding and implementation of the regulatory requirements in the early stages of the product life cycle will ensure and adequate development of the medical product under development.  The definition of