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!

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