Oct 12, 2023
EU MDR/IVDR
This article highlights the fundamentals of EU medical device regulation, highlight the top priorities for 2023, and explore how individuals and organizations can become more involved in the changing landscape. Table of Contents The European Union (EU) has implemented...
Read More
Feb 28, 2023
EU MDR/IVDR
The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
Read More
Mar 29, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on further improving the regulations in the sphere of medical devices, has published a new visual guide describing the approach to be applied when determining whether...
Read More
Mar 23, 2020
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...
Read More
Oct 17, 2019
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR). Medical Software Regulated...
Read More