Australia and Oceania
The Therapeutic Goods Administration (TGA), the medical device regulating authority, has published a final consultation paper dedicated to the Australian Unique Device Identification (UDI) System to be implemented in the country in the course of the ongoing...
EU MDR/IVDR
The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a detailed FAQ dedicated to the most important questions related to the Unique Device Identification (UDI) system established under the Medical Device Regulation...
FDA
The Food and Drug Administration (FDA) issued guidance dedicated to unique device identification (UDI). The policy covers issues related to compliance dates for Class I and unclassified medical devices, and also certain devices requiring direct marking. The present...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
EU MDR/IVDR
The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (or the MDR) replaces the Medical Device...
