Your are located outside of the European Union and want to sell your Medical Device in Europe. So you need an Authorized Representative. I answer all the question you can ask yourself on the Authorized Representative or EC Rep. Learn how to select one, why a Distributor is the wrong choice and how to change it
GSPR is available in Annex I of the EU MDR and IVDR. You should really start with that if you are trying to be CE marked.
If you have a Drug-Device combination product, it is important for you to read this article which contains all the details about the changes due to the new Medical Device Regulation EU MDR 2017/745
Since few years now a lot of companies are transitioning to an EU MDR project to continue sell their products to Europe. But how much does it cost? This is what we will reveal you in this article.
The UDI is one of the new innovation that comes with the new Medical Device Regulation MDR 2017/745 and also the IVDR 2017/746. On this article I tell you what you need to understand how to implement this new tool.
Within the new Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) you need to define who is your Economic Operator.
You want to classify your Medical Device with the new Medical Device Regulation 2017/745 (MDR 2017/745)? We offer your for that a Free PDF Form & a Cheat Sheet as infographic for the classification.
One pillar for compliance to MDR 2017/745 is the Technical Documentation. To help you build your files, I will help you understand each section and if needed I also built a template for you.