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EUDAMED Is Now Mandatory: What Medical Device Manufacturers Must Do Before November 2026
EUDAMED became mandatory on 28 May 2026. Legacy devices must be registered by 28 November 2026. The
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EUDAMED Is Now Mandatory: What Medical Device Manufacturers Must Do Before November 2026
On 28 May 2026, EUDAMED, the EU central database for medical devices, became mandatory. If you sell medical devices in the European market, registration is no longer optional. And if your installed base predates May 2026, you have until 28 November 2026 to catch up.
That is six months. For many manufacturers, it is not enough time. Not because the EUDAMED portal is hard to use, but because they do not know what they have in the field.
What EUDAMED Now Requires
Four modules became mandatory on 28 May 2026:
- Actor module: every manufacturer, authorized representative, importer, and system producer operating in the EU must hold a Single Registration Number (SRN). Without it, no regulatory activity proceeds.
- UDI/Device module: every device must be registered with its Basic UDI-DI (BUDI-DI) and complete product data before being placed on the EU market.
- NB/Certificates module: notified bodies upload certificates for newly certified devices.
- Market Surveillance module: competent authorities gain visibility into compliance status across the EU.
For new devices: registration must be completed before the first unit ships. No SRN, no market access. For legacy devices (anything placed on the market before 28 May 2026): registration must be completed by 28 November 2026, provided you intend to continue selling them.
The Legacy Device Problem
Most manufacturers are not worried about new product launches. Those have dedicated regulatory teams and structured timelines.
The problem is the installed base.
Devices sold under MDD or AIMDD frameworks, before UDI systems existed, often lack a Basic UDI-DI entirely. For these, EUDAMED requires a surrogate identifier: an EUDAMED-DI and an EUDAMED-ID. That means manufacturers must first identify every legacy device still on the EU market, map its technical data, create the EUDAMED-DI, and upload it at volume, in under six months.
One regulatory consultancy put it plainly: "Legacy devices constitute the majority of many portfolios." The data volume challenge is significant for organizations that have not yet begun.
Why the Installed Base Is the Real Bottleneck
EUDAMED registration requires knowing what you have sold. Specifically: which device models, which variants, which serial numbers are still active in the EU market.
For manufacturers running service operations from spreadsheets or disconnected CRM data, this is where compliance stalls. You cannot register what you cannot see.
The organizations that will meet the November 2026 deadline fastest are those with serial number level visibility into their installed base: a live record of every sold device, its configuration, its location, and its service history. That data is the raw material for EUDAMED registration.
sqanit tracks 1.2 million medical devices across 57 countries at this level. When a customer like Stryker needs to locate a specific device configuration in the field, that answer takes 29 seconds. The same precision that enables fast field service enables EUDAMED registration: you know exactly which devices are affected, which are already registered, and which need action.
sqanit is an official GS1 Germany Solution Partner, UDI native by design, not retrofitted. That means device identifiers are already structured the way EUDAMED expects.
What Manufacturers Should Do Now
- Confirm your SRN status in the Actor module. If your organization is not registered, this blocks everything else.
- Audit your legacy portfolio: which devices are still on the EU market and which will continue to be sold after November 2026. Devices you discontinue before then do not require EUDAMED registration.
- Identify devices without a Basic UDI-DI. These need an EUDAMED-DI created. This is not a trivial data exercise if your product master is fragmented across systems.
- Map your installed base to know which serial numbers are affected. If this data does not exist in a single place, that is the first bottleneck to address.
- Consider machine to machine integrationfor large portfolios. Manual EUDAMED data entry at scale is a compliance risk. Structured device data exported from your installed base system is more reliable.
The Six-Month Window
EUDAMED is live. The November deadline is fixed. For manufacturers whose legacy portfolios are documented device by device, the path forward is clear. For those still relying on spreadsheets and disconnected service records, the next six months will determine whether their devices stay on the EU market.
The first step is not EUDAMED. It is your installed base.
Frequently asked questions.
How do we get started?
Getting started usually takes a few weeks, not months. We first look at your device fleet and workflows, then define a pilot with around 200–500 devices. From there, we handle the setup and onboarding and typically go live within 6–12 weeks.
How long does onboarding take?
Most customers are up and running within 6–12 weeks from kickoff. This includes the initial setup, device tagging and rollout to the relevant teams. The exact timeline depends mainly on fleet size, data availability and the systems we need to connect.
Does sqanit require an app or login for end users?
No. Users simply scan the QR code with their phone camera and are taken directly to the relevant device information or service flow. There is no app to download and no account or login required for the end user.
How does sqanit work with the systems we already use?
sqanit is API-first and designed to work alongside your existing systems. Device records and service data can be exchanged through REST APIs and connected to systems such as ERP, CRM, service or asset-management platforms.
sqanit also supports GS1 and UDI standards and is a GS1 Germany Solution Partner, so existing device identifiers can be used rather than creating a separate identification structure.
Is sqanit secure and compliant?
sqanit creates a traceable record of device and service interactions at serial-number level, helping teams maintain the documentation needed for regulated service and quality processes.
The platform is hosted in the EU and designed in line with GDPR requirements. Access and permissions can also be managed based on user roles and responsibilities.