Last year, the European Commission has announced that EUDAMED 3 as one central aspect for the implementation of important medical devices regulation (MDR) and IVD regulation (IVDR) mechanisms, will not… Read More
The Medical Device Coordination Group (MDCG) has issued a guidance document that is intended to streamline audit processes and efforts under the medical devices regulation (MDR) and IVD regulation (IVDR).… Read More
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
mdi Europa is constantly screening various sources on news and guidance that could be of importance for medical device manufacturers. In this context, we came across two guidance documents that… Read More
The European Commission has officially recommended to postpone Regulation (EU) 2017/745 on medical devices (MDR) for one year. All eyes are on the EU institutions if the proposal will be… Read More
Performance evaluations will take an integral part in the CE Marking process of in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (IVDR). This article outlines,… Read More
Notified Bodies have a crucial role in the CE Marking process. Below you will find an overview of the role of Notified Bodies and what is important when selecting and changing… Read More
