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.
These tools are particularly suitable for small and medium-sized enterprises (SMEs) and large market players with compliance departments.
To help out, here is presented a detailed description of all the steps that the CE marking process can include.
Here, you can find answers to 5 questions often asked during a CE-marking consultation and request the help of professionals.
This article provides a brief overview of what a technical file is and what it should contain. Special attention will be given to the contents of the technical documentation for respiratory products (e.g. face masks) according to the PPE Regulation 2016/425.
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.