New phase of the implementation of the European medical device surveillance system
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SubscribeOn November 26, 2025, the European Commission (EU) announced the full operability of the first four modules of the European Medical Device Database ("EUDAMED") through Decision (EU) 2025/2371 of 26 November 2025, meaning their use will become mandatory from May 28, 2026.
Which modules will be compulsory?
Following an independent audit, the European Commission verified that the following electronic systems are functional:
- Register of economic operators: electronic system for the registration of economic operators as referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746.
- UDI database and product registration: electronic system provided for in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746.
- Notified bodies and certificates: electronic system as referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746.
- Market surveillance: electronic system as provided for in Article 100 of Regulation (EU) 2017/745 and Article 95 of Regulation (EU) 2017/746.
Impact on Spanish records
In Spain, as of May 27, 2026, the obligation to report to the national registers provided for in Royal Decree 1591/2009, which were maintained until EUDAMED became operational, will cease. From that date onwards, notifications to both the Register of Placing on the Market Communications ("CCPS") and the Register of Responsible Persons ("RPS") at national level will no longer be required. The reporting obligation will continue to apply to manufacturers of custom-made medical devices.
Notwithstanding the above, economic operators marketing medical devices in Spain must submit notifications to the future marketing register of the Spanish Agency for Medicines and Medical Devices ("AEMPS"), established under Article 18 of Royal Decree 192/2023, which will become mandatory once operational. Such notifications must be made within six months of the notification to EUDAMED. The AEMPS will provide further information on the implementation of this register in due course.
Impact on Portuguese records
In Portugal, when the Medical Devices Regulation was transposed into national law, a transitional regime was established requiring economic operators to register their products with Infarmed while EUDAMED was not yet fully operational and its use was not mandatory, as explained in a previous Post | Implementation of the Medical Devices Regulation.
Accordingly, once the EUDAMED obligation enters into force on May 28, 2026, these national registration obligations may no longer be enforceable, at least for manufacturers, authorized representatives and importers.
However, given the specific requirements for each category of economic operator, it will be necessary to await guidance from Infarmed to determine the precise impact of this change on national obligations.
Recommendation for economic operators
With just over two months until the modules become fully mandatory, it is essential that manufacturers, authorized representatives, importers and distributors review their registration status and complete any pending registrations and notifications in EUDAMED.
For more information, please contact our specialists through the Knowledge and Innovation Area.
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