Registration of medical devices

Registration of Medical Devices

Medical devices must be registered before they can be placed on the market in the EU/EEA. Registration takes place in EUDAMEDand includes information about the manufacturer, the device, and the identification of the product.

EMDN

EMDN is the nomenclature used to classify medical devices in EUDAMED. Each product must be assigned a relevant EMDN code during registration. The most precise code should be chosen, but in exceptional cases, multiple codes may be used. See more information on the European Commission's website.

UDI

UDI is a system for the unique identification of medical devices. The requirements for UDI apply independently of EUDAMED, and UDI codes must be registered along with the device.

Transition Period for Devices Placed on the Market Before May 28, 2026

For devices placed on the market before EUDAMED became mandatory, there is a six-month transition period before they must be registered in EUDAMED. This means these devices must be registered by November 28, 2026.

Legacy Devices

Legacy Devices are products certified under previous directives and can still be marketed during the transition period. These products must be registered in EUDAMED, even if they are not fully MDR-certified.

Custom-Made Devices

Custom-made devices are generally not required to be registered in EUDAMED, except for implantable devices in Class III. This is to ensure that the notified body can link the certificate for the device to an actual product.

The European Commission provides more information about the device module on its website.