Conformity assessment procedures for medical device manufacturers
According to most manufacturers, the notified body conformity assessment is the most challenging part of the CE marking process. This article outlines the general setup of the conformity assessment procedure. This video is an excerpt from the online course...
Authorised representatives, importers and distributors under the MDR
This article presents an overview of different stakeholders and the concept of the economical operators in relation to the MDR. The following video, which is a part of our online course Introduction to the Medical Device Regulation (EU) 2017/745, explains the topic...
UDI requirements for medical device manufacturers in the EU
This article provides a summary of the Unique Device Identifier (UDI) requirements. UDI will be applicable to all manufacturers of medical devices in the EU. If you would like to know more about the UDI requirements, please take a look at the video below. The video is...
Medical Device Regulation codes
The Medical Device Regulation codes, or MDR codes for short, specify what the notified bodies are designated for and thereby stipulate what category of devices the notified bodies can work with. The following video explains them in-depth, and it is a part of our...
What is a medical device according to the MDR
This article aims to answer the question of what is a medical device, and who is responsible for it, according to the MDR. The following video is a topic from our online course Introduction to MDR, Medical Device Regulation (EU) 2017/745, and you can register for it...
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