On 28 May 2026, four EUDAMED modules became mandatory: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance. Most manufacturers focused on the obvious rule: New MDR/IVDR devices must be registered before the first unit is placed on the market. The second deadline on November 28 has had less attention, and it is now only weeks away.
Regulation (EU) 2024/1860 amended the MDR and the IVDR to allow a phased roll-out of EUDAMED and to introduce certain transitional and supply-continuity measures. Commission Decision (EU) 2025/2371 was published in the Official Journal of the European Union (OJEU) on 27 November 2025. It formally confirmed that the first four EUDAMED modules meet the established functional specifications. Publication started a six-month transition period, so mandatory use began on 28 May 2026.
The Regulation also gave manufacturers additional time for devices whose first units were placed on the market before mandatory use began and which are still being placed on the market. That includes legacy devices and MDR/IVDR devices that weren’t registered voluntarily. These devices must be registered in EUDAMED by 28 November 2026.
Registration works at UDI-DI level. One missing UDI-DI can therefore affect a whole product line. And because many portfolios include hundreds of legacy device variants, this is where most companies are still behind.
On paper, registering devices that are already on the market sounds like a simple admin task. In practice, it rarely is. The information EUDAMED asks for is usually spread across several teams. Regulatory affairs, labelling, quality and supply chain each hold part of the picture, and no single person owns it all. Product data collected over many years can be incomplete or inconsistent, and it doesn’t always match what’s printed on the label. Gathering, checking and agreeing on that data usually takes far longer than the registration itself.
There won’t be an automatic fine on 29 November, and no switch in EUDAMED will block your products. Even so, missing the deadline will have real consequences:
1. Assess the gap now. List every UDI-DI still being placed on the EU market and check it against what is already in EUDAMED.
2. Prioritize. Start with high-volume devices, devices sold through importers or into public tenders, and devices linked to certificates your notified body needs to upload.
3. Have a plan B on paper. If some records won’t be in by 28 November, document the gap, the remediation plan and the timeline. If a notified body or a competent authority asks, a documented plan carries much more weight than having nothing to show.
4. Choose the right registration route. If you only have a handful of devices, registering them manually in the EUDAMED interface works well. With a larger portfolio, though, manual entry soon becomes slow and repetitive, and every record typed by hand is another chance for an error. With only three weeks left, XML bulk upload is usually the more practical option, because it lets you submit many records at once from data you already hold.
When companies fall behind, it’s rarely because they don’t know about the deadline. Their device data sits in spreadsheets, ERP exports and legacy files that aren’t in a format EUDAMED accepts. Turning that data into validated, EUDAMED-compliant XML is the step where most projects stall.
At Qserve, we help with exactly this step. We collect and extract your device data and handle the bulk submission for you. Because we manage large volumes of device data efficiently, we reduce the risk of errors and last-minute delays. If 28 November is looking tight, there’s still time to get there, but now is the moment to act. Learn more about our EUDAMED services or contact our team directly to avoid non-compliance.