CE marking of IVDs

30 March 2023

In vitro diagnostic medical devices may only be marketed after obtaining CE marking. CE marking is evidence that the device conforms to the in vitro diagnostic medical device legislation. In the case of in vitro diagnostic medical devices on List A or List B, or devices for self-testing, any such device must follow a conformity assessment procedure with the involvement of a notified body before the device can obtain CE marking. A notified body is a private organisation which has been authorised to assess the documentation submitted by the manufacturer. The notified body assesses if the documentation of the product's safety and performance is sufficient for the product to obtain CE marking.

CE marking is required for medical devices to move freely throughout the EU, provided that the devices meet any national requirements (such as registration and language requirements).