CE marking is the medical device manufacturer’s claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.
To understand which requirements you need to meet, you must classify the device and identify the appropriate conformity assessment route for your product. This dictates the required activities to demonstrate conformity.
We will review the route you chose to confirm its suitability, and work with you to execute the most efficient review process for the selected route. Our trusted review processes allow you to build reliability and confidence into your CE marking project planning.
MDR and IVDR Regulations
Learn more on European Regulations by visiting our dedicated webpages.