CE Marking
April 25, 2023
You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and the guidance documentation, you begin to doubt the CE mark process. Are [...]
February 28, 2023
Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]
October 18, 2022
CE marking indicates compliance with an EU directive so that you can market your products in the EU. It's that simple. CE marking is a voluntary conformity assessment procedure, but it is a requirement [...]
May 24, 2022
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for medical device manufacturers commercializing their devices in the European Union. For manufacturers of higher-risk devices (Class IIa, Class IIb, and [...]
July 21, 2019
CE Marking Process in the European Union Introduction This article will detail the various steps you will need to take for an entire CE Certification cycle for your product. [...]