In Vitro Diagnostic Medical Devices Regulation

The In Vitro Diagnostic Medical Devices Regulation lays down rules and regulatory requirements for in vitro diagnostic medical devices intended to be used by humans in the market of the EU.

This Regulation is also applicable to performance studies in vitro diagnostic medical devices and accessories conducted in the EU.

According to the definition elaborated by this regulation, in vitro diagnostic products are reagents, instruments, and systems used for the purpose of diagnosing disease or other conditions of the human.

Note that Class A sterile, Class B, Class C, and Class D devices need Notified Body involvement.

Product Examples

Below you find some examples of products that fall under the In Vitro Diagnostic Medical Devices Regulation:

• Red / blue nasal swabs
• Pregnancy test strips
• Blood test kit
• Urine test kit
• Covid-19 test kit
• HIV test kit

Learn More

a. Official Text of the Regulation