With the mandatory use of EUDAMED from 28 May 2026, medical device manufacturers will have access to a centralized EU system for registering economic operators and medical devices. However, EUDAMED does not necessarily completely replace national registration requirements. For manufacturers established in- and outside the EU, EUDAMED serves as the EU-wide registration system, but certain EU Member States may still require additional national registration or notification when devices are placed on their market.
EUDAMED: the EU-Wide Registration System
EUDAMED was established under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
For manufacturers, the key requirements are found in Articles 30 and 31 MDR and the corresponding provisions of the IVDR.
Before placing devices on the EU market, the relevant economic operators must be registered in EUDAMED.
For a manufacturer, this includes:
• Registration of the manufacturer as an economic operator;
• Registration of the EU Authorized Representative (where applicable);
• Obtaining the relevant Single Registration Number (SRN); and
• Registration of the manufacturer's devices in EUDAMED.
EUDAMED Modules
EUDAMED consists of six interconnected modules:
1. Actor Registration
2. UDI/Device Registration
3. Notified Bodies & Certificates
4. Market Surveillance
5. Vigilance & Post-Market Surveillance
6. Clinical Investigations & Performance Studies
The first four EUDAMED modules became mandatory on 28 May 2026, following the six-month transition period established under Regulation (EU) 2024/1860. The remaining modules are still being developed and will become mandatory when the applicable legal conditions are met.
What About Devices Already on the Market?
Manufacturers should also be aware of the transition deadline for devices already placed on the EU market. Devices that were already on the market when the UDI/Device module became mandatory on 28 May 2026 must generally be registered in EUDAMED within 12 months of the publication of the European Commission's notice, by 28 November 2026, if they will continue to be placed on the EU market.
For legacy devices, where the same device is already registered in EUDAMED under the MDR or IVDR, a separate registration may not be required, depending on the applicable device and registration rules. Manufacturers should therefore review their existing device portfolio and determine which devices require registration by 28 November 2026.
The 28 November 2026 deadline for legacy device registration is approaching. If you are still facing challenges with data collection, extraction or the controlled conversion of device data into EUDAMED-compliant XML, now is the time to act. Our EUDAMED Bulk Upload Service supports you throughout the submission process, from initial data structuring and XML generation to XSD and business rule validation. We help manage large volumes of device data efficiently and reduce the risk of errors or last-minute delays.
Don’t leave your legacy device registrations until the final weeks. Learn more about our EUDAMED services and contact our team to get your submissions on track before the deadline.
Does EUDAMED Replace National Registration?
EUDAMED is intended to create a centralized EU system and significantly reduce duplicate registrations. However, national requirements have not disappeared completely. The MDR & IVDR allow certain national registration requirements to remain, particularly in relation to distributors. In addition, individual Member States may maintain national requirements concerning the registration or notification of devices or economic operators under their national legislation.
For a manufacturer, the important question is therefore:
Is there an additional national requirement applicable to the device or economic operator placing the device on that particular national market?
This does not necessarily mean that the manufacturer itself has to obtain another national registration. In some cases, the obligation is placed on the economic operator commercializing the device in that EU Member State.
Examples of Additional National Requirements
Spain.
In addition to the applicable EUDAMED requirements, Spain has introduced a national registration requirement for economic operators marketing medical devices and IVDs in Spain. Under Royal Decrees 192/2023 and 942/2025, economic operators marketing products in Spain must be included in the AEMPS Marketing Register (RECOPS), with the exception of custom-made devices, which are subject to a separate registration procedure.
Slovakia.
Slovakia maintains a national notification requirement alongside the mandatory use of EUDAMED. According to the Slovak competent authority, ŠÚKL, a manufacturer, Authorized Representative, importer or distributor that makes a medical device or IVD available on the Slovak market must notify ŠÚKL within 14 days of the device first being made available on the Slovak market.
This national notification requirement remains in place alongside the mandatory EUDAMED requirements that apply from 28 May 2026. An exemption applies to Class I medical devices and Class A IVDs, unless ŠÚKL specifically requests notification and the relevant documentation.
Cyprus.
Cyprus maintains a national notification requirement alongside the applicable EUDAMED requirements. According to the Cyprus Medical Devices Authority (CYMDA), any person placing medical devices or IVDs on the Cypriot market is required to notify CYMDA of the relevant products. This notification requirement applies even where the device has already been appropriately registered in another EU/EFTA country.
What Should Manufacturers Do?
Manufacturers should assess both their EUDAMED obligations and any applicable national requirements to ensure full compliance across the EU. Before entering a new EU Member State, manufacturers should verify:
• Is the manufacturer registered in EUDAMED?
• Is the EU Authorized Representative registered and active, if applicable?
• Has the SRN been issued?
• Are the relevant devices registered in EUDAMED?
• Does the target EU Member State have an additional national registration or notification requirement?
• Who is responsible for that national requirement: manufacturer, Authorized Representative, importer or distributor?
• Does the requirement apply to all devices or only certain classifications/types?
• What are the national deadlines and applicable fees?
Need support with EUDAMED or national registration requirements? Contact Qserve for assistance with assessing your obligations and managing the registration process across the EU.