For manufacturers who wish to place a medical device on the European market, CE marking is a conformity process supported by a technical file under the MDR.
What does a technical file generally contain?
- Product description and intended purpose
- Risk management work
- Clinical evaluation
- Instructions for use and labelling
- Manufacturing and quality system information
The benefit of early preparation
The earlier gaps are noticed, the more orderly testing and documentation work can be. The product’s class and the target market determine the route, so it helps to begin with a roadmap.
This article is general information, not a diagnosis or treatment recommendation. Consult a physician for a personal assessment.
