EUDAMED is coming (in 2026!) – Mind your Basic UDI-DI!

EUDAMED has been long in the making, but the European Database for Medical Devices will become a reality in 2026. EUDAMED will be a powerful tool for the authorities supporting their market surveillance activities. This presents a challenge for companies because they will be responsible for their data. EUDAMED will use the Basic UDI-DI to identify a device family in EUDAMED, and it will also have to be used to identify the device in the technical documentation. The Basic UDI-DI will therefore be the link between the device in the European database and the evidence demonstrating compliance.

A single Basic UDI-DI covers all devices with the same risk class, the same intended purpose and the same essential design and manufacturing characteristics. Device groupings currently used for legacy devices may be based on other principles.

This webinar will provide you with insights the verify if your device families are correct. In case you need to correct this, the webinar will provide you with guidance on what to do and when.

Ronald Boumans from Munich Medtech , who became involved with EUDAMED almost 20 years ago when he was working for the Dutch competent authority, will provide useful insights about EUDAMED and the use of UDI.

Liat Aharon Pollak from R.S NESS Group is a regulatory expert with a wide experience in creating compliant technical documentation for medical devices.

EUDAMED is coming; review your Basic UDI-DI to prepare.