For medical device and IVD manufacturers in Europe, EUDAMED is moving from something to prepare for into something that must be actively managed.
The timeline is now clear. Following the European Commission’s notice that the first four EUDAMED modules are functional, mandatory use begins on 28 May 2026 for Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. This applies under both MDR and IVDR.
For many companies, the practical challenge is not understanding that EUDAMED matters. It is understanding what needs to be done, in what order, and how to avoid creating gaps between regulatory data, technical documentation, and internal processes.
From preparation to mandatory use
EUDAMED has been introduced through a gradual roll-out model. Under Regulation (EU) 2024/1860, each module becomes mandatory six months after the publication of the notice confirming its functionality. For the first four modules, that notice was published on 27 November 2025, which is why mandatory use starts on 28 May 2026.
This changes the role of EUDAMED in day-to-day regulatory work. It is no longer only a future requirement or a system to familiarise yourself with. For the relevant modules, it is now part of the practical pathway to market access and compliance.
The key dates companies need to track
The first immediate requirement is Actor Registration. Manufacturers, authorised representatives, and importers need to be registered in the Actor module, and manufacturers outside the EU must also have the appropriate authorised representative setup in place for registration. Actor registration is a foundational step because it enables the use of other modules and supports access to the Single Registration Number, or SRN.
From 28 May 2026 onward, new devices under MDR and IVDR must be registered in the UDI/Device module before being placed on the market. For legacy devices and regulation devices whose first unit was already on the market before mandatory use began, the deadline to register them in the UDI/Device module is 28 November 2026. Devices no longer being placed on the market by the time the module became mandatory do not need to be registered unless a vigilance action occurs.
The same staggered logic applies to the Notified Bodies & Certificates module. New MDR and IVDR certificates issued after mandatory use begins must be registered in EUDAMED from that point onward. For valid certificates issued before the module becomes mandatory, notified bodies have until 28 May 2027 to upload the related information.
Market Surveillance will also become mandatory on 28 May 2026 as part of the first wave. That means EUDAMED is not only about initial registration. It will also become part of how authorities oversee products and follow up on compliance activities.
Where companies commonly get delayed
In practice, delays often come from three areas.
The first is Actor Registration not being completed early enough. Since this underpins access to later steps, delays at actor level can affect everything that follows.
The second is incomplete device data preparation. UDI structures, legacy device identification, and certificate-linked product information often need more internal review than expected before they are ready for submission.
The third is assuming EUDAMED can be handled as a separate administrative task. In reality, registration readiness depends on broader documentation control and on the consistency of regulatory data across systems and teams.
How to approach the deadlines now
For companies that have not fully prepared yet, the most practical approach is to break the work into stages.
The first priority is to confirm actor status and access readiness. The second is to review device portfolios and identify which products are new devices, which are legacy devices still on the market, and which certificates require data upload during the transition period. The third is to check whether internal data structures and technical documentation are aligned with what EUDAMED requires.
From there, the focus shifts to ongoing maintenance. EUDAMED is not a one-off submission exercise. Once the relevant modules are mandatory, companies need processes to keep data current as products, certificates, and market status evolve.
EUDAMED readiness is also a process question
For many organisations, EUDAMED readiness is best treated as a quality and regulatory process question, not just a platform question.
If the underlying documentation, ownership, and data control are clear, the system becomes much easier to manage. If they are fragmented, the deadlines create pressure very quickly.
That is why preparation often benefits from a structured review of current readiness, device scope, registration obligations, and the internal processes needed to support ongoing compliance.
Moving forward with a clear plan
The deadlines are now close enough that EUDAMED preparation needs to be operational, not theoretical.
For many manufacturers, the work starts with confirming SRN-related readiness and preparing product data for registration. For others, the focus is already on legacy device uploads and certificate transition planning. In all cases, the common requirement is the same: accurate, controlled, and up-to-date regulatory data.
If your organisation is preparing for EUDAMED deadlines under MDR or IVDR, MDS supports teams with practical readiness work, data and documentation alignment, and the regulatory processes needed to keep submissions accurate and manageable.
You can contact us at Kristian@mdsdenmark.dk or via Book a Meeting.