Consulting

On November 27 marked a turning point in the medical devices sector. The European Commission published the Decision (EU) 2025/2371, by which four EUDAMED modules have been officially declared mandatory. Until now, its use was voluntary, but the new decision establishes a mandatory compliance framework. If you don’t want to fall behind and need to understand what changes for your company, keep reading: we explain what EUDAMED is, which modules are being activated, who is affected, and the practical steps you need to take. What is EUDAMED and why is it important? EUDAMED is the large European database created by the Regulation (EU) 2017/745 (MDR) and the Regulation (EU) 2017/746 (IVDR). Its mission is clear: centralize and facilitate access to all information about medical devices and IVDs marketed in the EU and guarantee a complete traceability across all stages of the device lifecycle. is formed by six modules, which span from the registration of economic operators to post-market surveillance. What does EUDAMED aim to achieve? ● A stronger oversight by competent authorities. ● Harmonize the entry and supervision of products in the European market. ● Increase the transparency and public trust. ● Improve the traceability, from manufacture to market withdrawal. To achieve this, key information is gathered about manufacturers, economic operators, devices, certificates, clinical studies, incidents and corrective actions. How many modules is EUDAMED made up of? EUDAMED is divided into 6 modules, although only 4 have been officially declared functional and mandatory. The modules are: 1. Actor Registration (Registration of economic operators). 2. UDI / Device Registration (Unique Device Identifier and device registration). 3. Notified Bodies & Certificates (Certificates and Notified Bodies). 4. Vigilance & Post-Market Surveillance (Vigilance and post-market surveillance). 5. Clinical Investigations & Performance Studies (Clinical investigations and performance studies). 6. Market Surveillance (Market surveillance). Next, we explain each of the mandatory modules. 1. Actor Registration – Registration of Economic Operators (SRN) It is the module where all manufacturers, authorized representatives and importers must register. Upon completing the registration, the SRN (Single Registration Number) is assigned, essential to operate in the European market. Why is it mandatory to obtain an SRN? Because without an SRN you will not be able to carry out any regulatory activity in the other modules (UDI registration, certificates, vigilance…). What do you need to obtain it? ● Identification data of the company. ● Proof of legal establishment. ● Documentation validated by the competent authority of the Member State. ● Declarations and certificates corresponding to MDR/IVDR. Who must register? ● Manufacturers of medical devices and IVDs. ● Importers established in the EU. ● Authorized representatives of non-EU manufacturers. ● Notified bodies. ● Entities subject to market surveillance and control. 2. UDI / Device Registration – Device Registration It is one of the most critical modules. Every device marketed in the EU must have a Unique Device Identifier (UDI) and be registered in EUDAMED. What is the UDI? It is a unique alphanumeric code that unequivocally identifies a device on the market. Types of identifiers ● Basic UDI-DI (Basic UDI-DI): It is the main identifier that groups a family of products with the same intended use, risk class, design and manufacturing.7 ● UDI-DI (Device Identifier): It is the fixed part of the UDI. Identifies a specific device and its version or model. ● UDI-PI (Production Identifier): It is the variable part of the UDI, which identifies information related to the production of the device. (lot number, serial number, manufacturing date, expiry date …) Information to be included: ● Brand name of the product. ● Risk category. ● Intended purpose. ● Certification data (if applicable). UDI advantages ● Greater traceability. ● Better management of recalls, safety alerts and corrective actions. ● Greater transparency in post-market surveillance. ● Greater transparency and easier access to information. What if I already have products on the market? Devices marketed before the mandatory implementation will have a 12-month window to complete registration (legacy devices). 3. Notified Bodies & Certificates – Certificates and Notified Bodies This module centralizes information about CE certificates issued under MDR and IVDR. Who does this affect? ● Notified bodies. ● Manufacturers whose products require conformity assessment. What is registered here? ● Certificates issued. ● Renewals, amendments or supplements. ● Suspensions or withdrawals. Manufacturer obligation You must ensure that your Notified Body properly uploads the certificate information into EUDAMED and validates those certificates. If the certificate does not appear or is incomplete, it can jeopardize your market clearance. 4. Market Surveillance Module Affects primarily competent authorities, although it indirectly impacts manufacturers and authorized representatives. What does this module cover? ● Actions taken by market authorities. ● Surveillance, inspections and corrective measures. Why does it affect you? Because the information you upload in the other modules will be used by authorities to verify your company's conformity. 5. Vigilance & Post-Market Surveillance (Not yet mandatory) This module is still under development and will be mandatory when the Commission publishes its functionality. It will collect: ● Serious incidents. ● Field safety corrective actions (FSCA). ● Periodic post-market surveillance reports. 6. Clinical Investigations & Performance Studies (Not yet mandatory) Module also pending publication. It will include: ● MDR clinical investigations. ● IVDR performance studies. ● Monitoring and authority decisions. Why these 6 modules in EUDAMED? The European Commission's goals are clear: ● To increase the transparency in the medical devices market. ● To ensure end-to-end traceability. ● To improve coordination among member states. ● To facilitate communication between manufacturers and Notified Bodies. When will EUDAMED be mandatory? According to the Regulation (EU) 2024/1860, each module becomes mandatory six months after the Commission posts the notice of full functionality. With Decision (EU) 2025/2371, published on November 27, 2025, the first four modules will be mandatory from May 28, 2026. What about the other two modules? The modules of Vigilance & PMS and CI/PS are under development and are expected to be mandatory from 2027, although final dates depend on the Commission's official notice. What happens if I do not meet EUDAMED requirements? Consequences can be serious: ● Inability to market unregistered products. ● Blockage of activities for companies without SRN. ● Certificates not accepted if not properly uploaded. ● Interruption of imports due to lack of importer registration. The recommendation is clear: start as soon as possible. Data entry, document review, and validation take time and resources. Do you need help complying with EUDAMED? Our MDR/IVDR expert team can help you with: ● Obtaining the SRN. ● UDI-DI and UDI-PI registration. ● Technical review for data upload. ● Compliance strategy and planning. 👉 Contact today with our technical team of experts in the healthcare industry and start complying with EUDAMED.

What is EUDAMED and which modules are mandatory for medical device manufacturers?

Automotive Consulting Solutions and Industry 4.0 Companies

Tell us what you need

Normative compliance

certifications

We celebrate