CE Marking of In Vitro Diagnostic Medical Devices

This guide is related to the CE marking according to the directive 98/79/EC and does not apply in the framework of the Regulation (EU) 2017/746.

IVDs (in vitro diagnostic devices) play an important role in the diagnosis and treatment of diseases around the world, including Europe. As with medical devices, the regulations for marketing IVDs in the European Union requires that the manufacturer follow a conformity assessment route to show that their IVD conforms to essential requirements.

However, because of the inherent differences between medical devices that fall under the MDD and IVDs, they have their own essential requirements and different classification rules and common technical specifications…

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