Medical Devices in European Union need a EC mark to be put on the market. Easy Medical Device will help you to understand how to do a lot of things alone. Without having to hire a consultant.
The ISO 13485 standard is also important if your are a Medical Device Manufacturer. I will provide you all what you need to pass the audit with the Notified Body.
If you are located outside of European Union, you need to appoint a European Authorized Representative. Learn how to choose it.
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.
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.
You should absolutely get prepared for a Notified Body audit and in this article, I give you the keys for it.
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.
When you run an MDR or IVDR project there can be some issues. In this article we list some of the pitfalls.
The Medical Device Regulation (EU MDR 2017/745) and the In-Vitro Diagnostic Regulation (EU IVDR 2017/746) do have a different transition period. But what you’ll learn on this article will surprise you as there are different transition period even inside the MDR. A Hard transition and a Soft one. Learn how to distinguish them.
Is you 3D printed Medical Device considered as Custom Made by the regulations. Read this article to understand that there is a complete change on the MDR 2017/745 that can affect manufacturers. Additive manufacturing is an innovative process to explore for medtech industry but before to start you need to know that there are still some work to do to be compliant with the new regulation.
