How to identify a medical device?
The name of the medical device and its intended purpose must be clearly indicated on the packaging or the product. Devices under the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR) must bear a MD or an IVD symbol or information clearly stating that it is a medical device or an in vitro diagnostic medical device.
Each medical device must be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.