This article helps you understand what an EU authorised representative is and what their general responsibilities are.
This article provides guidance on what documents MedTech manufacturers must include in their medical device technical files. The article also shares insights on how a medical device technical file is assessed for MDR compliance.
MedTech manufacturers can use the present guidance on medical device symbols to comply with the new, stricter MDR labelling requirements.
This post focuses on the medical device labelling requirements and user manual requirements under the EU MDR 2017/745.
This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.
The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.
Manufacturers who want to place their medical devices on the European market must refer to the Medical Device Regulation (MDR) 2017/745 to determine the appropriate risk class of their devices.