Mandatory Eudamed registration from May 28, 2026

On November 27, 2025, the notice of full functionality of the first four modules of Eudamed was published in the Official Journal of the European Union. The four modules will therefore become mandatory from May 28, 2026.

Eudamed consists of six interconnected modules and a public site, accessible to operators and lay persons. The full functionality communication concerns the following systems:

• The electronic system for the registration of economic operators referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746;
• The UDI database and the electronic system relating to the registration of devices referred to in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746;
• The electronic system for notified bodies and certificates referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746;
• The electronic system for market surveillance referred to in Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.

Regulation (EU) 2024/1860 (issued in June 2024 and entered into force the following January), which, among various amendments and additions to Regulations (EU) 2017/745 and 2017/746, provided an important innovation regarding the mandatory use of Eudamed: no longer tied to the full operation of the entire platform, but linked to the individual module. Each module is therefore evaluated individually, and the countdown for mandatory use starts precisely from the publication of the relevant notice in the Official Journal.

The completion notice corresponds to the start of a 6-month countdown for adaptation by the interested operators.

Device registration in Eudamed

The most critical issue certainly concerns the second point, namely the registration of devices and the related UDI database. This is indeed a process that requires considerable time and resources and requires defining a plan to adequately respond to regulatory requirements.

Devices for which registration is mandatory

• Device for which no equivalent version compliant with the Regulation already registered in Eudamed exists (if Legacy device) and the first unit will be placed on the market at or after the expiry of the 6-month period that makes the use of the module mandatory: obligation to register the device before placing it on the market.
  
• Device for which no equivalent version compliant with the Regulation already registered in Eudamed exists (if Legacy device), the first unit was placed on the market before the expiry of the 6-month period that makes the use of the module mandatory and other units will be placed on the market after the 6-month period: obligation to register the device if vigilance activities are necessary, otherwise within 12 months from the publication of the functionality notice.

Devices for which registration will not be mandatory (unless vigilance activities are necessary)

• Custom-Made or Old Device: registration will not be mandatory (except in cases where vigilance activities on the product are necessary).
  
• Legacy Device for which a corresponding version compliant with the Regulation already registered in Eudamed exists: registration will not be mandatory (except in cases where targeted vigilance activities for the Legacy device are necessary).
  
• Devices for which the individual sales units will no longer be placed on the market after the expiry of the 6-month period that makes the use of the module mandatory: registration will not be mandatory (except in cases where vigilance activities are necessary).

Bulk upload system

Eudamed does not provide an easily accessible system for bulk uploading of UDI codes and, in many cases – especially for manufacturers managing numerous codes derived from different variant combinations – the registration process is particularly burdensome in terms of time and resources.

During this period, in addition to being recognized as reference figures in the Eudamed and UDI field – with presentations at national industry events – we have developed a bulk upload system for medical devices in Eudamed, which allows for a significant reduction in the effort required from the manufacturer and related costs.
Despite the high level of automation, the process always includes a human consistency check: a thorough analysis to ensure that the data entered complies with current regulations and the rules for obtaining and assigning UDI codes.