Jun 23, 2022 | Articles, Medical device regulation |
The main purpose of the EUDAMED database is to enhance traceability, cooperation, and transparency regarding medical devices in EU. The database is huge and has been split up into six different modules with specific purposes. This article will cover the areas that...
Jun 21, 2022 | Articles, Medical device regulation |
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...
May 16, 2022 | Articles, Medical device regulation |
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...
May 12, 2022 | Articles, Medical device regulation |
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...
Feb 4, 2022 | Articles, Medical device regulation |
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...
Dec 8, 2021 | Articles, Medical device regulation |
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...