What the 2026 Deadlines Mean for Medical Device and IVD Manufacturers
EUDAMED mandatory timelines for MDR and IVDR are no longer theoretical. On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371 in the Official Journal of the European Union. This Decision confirms that four EUDAMED modules are now functional: Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance.
Under the amended transitional rules in Regulation (EU) 2024/1860, that publication starts a six-month transition. As the Commission’s EUDAMED overview explains, from 28 May 2026 these four modules become mandatory to use for both medical devices and IVDs.
For manufacturers, authorised representatives, importers and notified bodies, this creates fixed dates that must now sit inside MDR and IVDR compliance plans.
1. How the EUDAMED Gradual Roll-Out Works
Regulation (EU) 2024/1860 amends the MDR and IVDR so that EUDAMED can go live module by module. Instead of waiting for all six modules, the Commission can audit each module or group of modules, confirm functionality, and then publish a notice in the Official Journal.
Once that notice appears, the rules change in a clear way. According to the Commission’s Q&A on the gradual roll-out of EUDAMED, the obligations and requirements linked to a given module become applicable six months after the notice is published. Until that date, the relevant provisions of the old Directives and their national transposition measures still apply for registration duties.
The same Q&A explains that some modules also come with extra time:
- For the UDI/Device module, manufacturers have up to 12 months from the Official Journal notice to register certain devices already on the market.
- For the Notified Bodies and Certificates module, notified bodies have up to 18 months from the notice to upload information on existing MDR and IVDR certificates.
Because the notice for the four modules appeared on 27 November 2025, the six-month period runs to 28 May 2026. After that date, the four modules are no longer optional.
2. Module-by-Module Deadlines Under MDR and IVDR
2.1 Actor Registration: SRNs Before Placement on the Market
The Actor module covers registration of economic operators. It applies to manufacturers, authorised representatives and importers that fall under Article 31 MDR and Article 28 IVDR.
The Q&A makes one point very clear. These economic operators must register as Actors and obtain a Single Registration Number before a device is placed on the market. Registration in the Actor module also unlocks other actions in EUDAMED, such as device registration and vigilance reporting.
Because the Official Journal notice for the four modules was published on 27 November 2025, use of the Actor module becomes mandatory from 28 May 2026. Manufacturers and authorised representatives can already register voluntarily and the Commission strongly encourages early registration to avoid a last-minute rush.
2.2 UDI/Device Registration: New vs. Ongoing Devices
The UDI/Device (UDI/DEV) module holds device and system/procedure pack data at the level of the UDI-DI or EUDAMED ID. The Q&A describes how the timelines work for different device situations.
First, if a medical device or IVD under the MDR or IVDR has its first sales unit placed on the EU market on or after the date when UDI/DEV becomes mandatory, the manufacturer must register the device in EUDAMED before that first placement. In practice, this means that any new MDR or IVDR device with a first unit sold on or after 28 May 2026 requires registration in UDI/DEV in advance.
Second, if the first unit of a device entered the EU market before the mandatory date, but the manufacturer will place more units on the market after that date, the device must still appear in UDI/DEV. In this case, the Q&A gives manufacturers 12 months from the publication of the Official Journal notice to register those devices. Because the notice was published on 27 November 2025, this deadline falls on 27 November 2026.
Devices that will not be placed on the market anymore when UDI/DEV becomes mandatory generally do not need registration, unless a specific post-market surveillance or vigilance action for that device occurs.
2.3 Notified Bodies and Certificates: New and Legacy Certificates
The Notified Bodies and Certificates (NB/CRF) module contains MDR and IVDR certificates and related NB decisions. The Q&A again draws a line between future and past certificates.
Once NB/CRF becomes mandatory, notified bodies must register every MDR and IVDR certificate they issue from that date onward, together with updates and certain decisions that affect these certificates. For the four modules declared functional in November 2025, this obligation starts on 28 May 2026.
For certificates that notified bodies issued before that date, the Q&A gives them more time. They must upload information on existing MDR and IVDR certificates within 18 months of the Official Journal notice, provided the related devices need to be registered in UDI/DEV. With a notice date of 27 November 2025, that 18-month period ends on 27 May 2027. Only the latest version of a certificate and the latest relevant NB decision need to appear in EUDAMED.
2.4 Market Surveillance: A New Tool for Authorities
The Market Surveillance (MSU) module supports market-surveillance work by national competent authorities. Manufacturers do not directly enter data into this module. However, they will feel its effects because it strengthens coordination between authorities and gives them a harmonised IT tool for cross-border cases.
The Q&A applies the same six-month rule to the MSU module. As a result, competent authorities must use the MSU module from 28 May 2026.
3. Practical Impact of EUDAMED Mandatory Timelines for MDR and IVDR
3.1 What Changes for Manufacturers and Authorised Representatives
For manufacturers and authorised representatives, EUDAMED becomes a central part of regulatory operations rather than a future project. Several changes now follow from the fixed dates.
First, Actor registration turns into a gatekeeper. From 28 May 2026, manufacturers, authorised representatives and importers in scope of Article 31 MDR and Article 28 IVDR need their Actor registration and Single Registration Number in place before they place devices or IVDs on the EU market. Without this registration, they cannot complete device registration or use other EUDAMED functions.
Second, device master data becomes more strategic. New MDR and IVDR devices must have device records ready before first placement after 28 May 2026. Devices that are already on the market but will continue after that date require registration by 27 November 2026. Manufacturers now need structured UDI-DI hierarchies, clear product groupings and consistent trade names across their documentation.
Third, manufacturers must align device data with certificate data. For many products, public EUDAMED information will combine UDI/device data and NB certificate data. If these do not match, authorities and customers may question the status of a device. Coordination between regulatory, quality and IT teams becomes more important than ad-hoc, product-by-product corrections.
3.2 What Changes for Notified Bodies
Notified bodies also face a significant workload. They must register all MDR and IVDR certificates issued from 28 May 2026 and bring existing certificates onto the NB/CRF module by 27 May 2027.
Because many notified bodies hold large portfolios, they will need efficient tools to manage uploads. The Commission has provided documentation for manual, bulk and machine-to-machine data exchange with EUDAMED. However, each notified body still has to implement and validate its own approach. Manufacturers should talk to their notified bodies early to understand how and when certificate information will appear in EUDAMED and how that timing aligns with their own device registrations.
3.3 Portfolio Planning and Transitional Provisions
The EUDAMED roll-out also interacts with other MDR and IVDR changes. Regulation (EU) 2024/1860 extends some IVDR transitional timelines for certain IVDs, but EUDAMED obligations apply regardless of those extensions. A device might benefit from longer time to move from IVDD to IVDR certification and still require EUDAMED registration within the new deadlines.
At the same time, the amended Articles 123 MDR and 113 IVDR help to avoid double work. Until the EUDAMED deadline for each module, national systems based on the old Directives continue to apply. Once the EUDAMED obligations become mandatory, they replace those older mechanisms and remove the risk of duplicate registrations.
For global organisations, this means EUDAMED is now a core input into portfolio and lifecycle planning, not just a technical IT project.
4. How MDx CRO Can Support EUDAMED Readiness
MDx CRO specialises in supporting medical device and IVD companies through MDR and IVDR. The new EUDAMED mandatory timelines for MDR and IVDR increase the value of structured, data-driven support.
4.1 Strategy and Gap Assessment
MDx CRO can review your product and certificate portfolio and map it against the new deadlines. This includes checking which legal entities need Actor registration, which devices will still be placed on the EU market after May 2026, and where device and certificate data must align.
We can then build a practical roadmap that sequences Actor registration, device registration and interactions with notified bodies. This approach reduces the risk of late surprises when EUDAMED becomes mandatory.
4.2 Data Preparation for UDI/DEV and NB/CRF
We help teams design clear UDI-DI structures and basic device data sets. That work supports both UDI/DEV registration and internal quality systems.
MDx CRO can also support data cleansing and consistency checks so that the information you load into EUDAMED matches your technical documentation, declarations of conformity and certificates. This preparation lowers the chance of errors and reduces back-and-forth with authorities or notified bodies.
4.3 Integration Into Clinical and Regulatory Programmes
EUDAMED should sit alongside performance evaluation, clinical data generation and labelling work, not apart from it. MDx CRO can help you embed EUDAMED milestones into your MDR and IVDR programmes so that regulatory submissions, certificate planning and EUDAMED entries move together.
We also support communication with notified bodies on certificate upload planning and with national competent authorities where clarifications are needed.
5. The Bottom Line: The EUDAMED Clock Is Now Running
With Decision (EU) 2025/2371 published and the Commission confirming that the first four modules will be mandatory from 28 May 2026, the EUDAMED project has crossed a line. The remaining time to prepare is now measured in months, not years.
For medical device and IVD manufacturers, the message is straightforward. The EUDAMED mandatory timelines for MDR and IVDR fix near-term deadlines for Actor registration, device and UDI data, certificate uploads and market-surveillance tooling. Organisations that act now will spread the workload and reduce risk. Those that wait may face crowded registries, limited notified body bandwidth and internal bottlenecks.
If you want to test your EUDAMED readiness or build a structured plan to meet the 2026 and 2027 dates, MDx CRO can support you with strategy, data preparation and regulatory execution.
