Tag: Unique Device Identification

Updated Q&A document on MDR and IVDR UDI requirements from the European Commission

August 12, 2020

The European Commission has updated its Q&A document on UDI requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The paper provides answers to… Read More

Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

June 14, 2019

by Oliver Giesemann

The Medical Devices Coordination Group (MDCG) has published a number of guidance documents on the topic of UDI over the past months. More recently, the MDCG issued guiding principles for… Read More

Tag: Unique Device Identification

Updated Q&A document on MDR and IVDR UDI requirements from the European Commission

Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

MDCG guidance on administrative practices and technical alternatives until EUDAMED full functionality

Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons

European Commission publishes Q&A guidance on COVID-19 tests