Guide – Road to CE mark

The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.

In this guide, you will find:

• Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.
• Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
• Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.
• Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.

Download our guide and start your road to CE mark!