EUDAMED a synthesis for 2025 and the roadmap to 2026

1) The EUDAMED Turning Point

2025 was the year of the shift. On 27 November 2025, the European Commission published in the Official Journal of the European Union Commission Implementing Decision (EU) 2025/2371, confirming the full functionality of four EUDAMED modules: Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance. This publication triggers a six-month transition period: use becomes mandatory on 28 May 2026.

For manufacturers, EUDAMED is no longer an option – it is the condition for access to the European market and the transparency and traceability lever required under the MDR/IVDR.

In this trajectory, Ackomas has established itself as a strategic, go-to partner to secure your compliance: a solution operational since 2021, robust M2M integrations, regulatory coaching, and proven results through large-scale, error-free publications. In 2025, Ackomas supported many industry stakeholders with guides, webinars, and partnerships to demystify EUDAMED and de-risk projects.

2) What Changes Starting 28 May 2026

Mandatory modules

• Actors (SRN): registration of all economic operators (manufacturers, authorized representatives, importers, SPP producers). The SRN becomes the prerequisite for any activity.
• UDI/Devices (UDI-DI):
• New devices: registration before first placing on the market (after 28 May 2026).
• Devices under MDR or, where applicable, “legacy” devices (already on the market as of 28 May 2026): registration no later than 27 November 2026.
• Notified Bodies (NBs) & Certificates: NBs must upload their certificates, with a transition period extending to 2027 depending on the date of issuance.
• Market Surveillance: competent authorities will transition to this module for their control activities.

Modules to come

• Vigilance: targeted audit in Q2 2026 and likely mandatory use in Q3 2026, subject to confirmation.
• Clinical investigations / performance studies: ramp-up expected in 2027.

Specific cases

• Custom-made: limited data mainly in the EUDAMED Vigilance module.
• Distributors: no registration at EUDAMED level (national requirements may still apply).
• Master UDI-DI for highly individualized devices (e.g., contact lenses, spectacle frames, spectacle lenses and ready-made spectacles) – mandatory implementation as of 9 November 2026 for contact lenses and 2028 for frames/lenses/ready-made spectacles.

3) The Risks If You Wait

• Market access compromised: without an SRN and UDI registrations, placing your new devices on the market is impossible.
• Backlog effect: a considerable volume of EUDAMED registrations pushed to late 2026, creating a high risk of delays, errors, and additional costs.
• Data quality and completeness: non-compliant fields lead to rejections in EUDAMED.
• Updates and traceability: significant changes must be controlled to avoid inconsistencies between manufacturers’ information systems and EUDAMED.
• Audit non-conformities: Notified Bodies and competent authorities will verify EUDAMED compliance. Any deviation can lead to costly corrective actions, or even certificate suspensions.
• Snowball effect: non-compliance in Europe can impact your image and audits in other markets (FDA, etc.), as authorities and partners monitor overall consistency.
• Reputation and credibility: a manufacturer behind on EUDAMED may be perceived as noncompliant or unreliable by customers, distributors, and authorities – a direct risk to reputation and trust.

4) How Ackomas Prepared the Ground

Education and support (2025)

Major “industry” webinars:

• 4 July 2025 – SNITEM (France): session dedicated to the Devices module and operational impacts, with a customer testimonial and ANSN participation.
• 1 December 2025 – FENIN (Spain): status update after OJEU publication, lessons learned, and execution timeline.
• 11 December 2025 – BVMed (Germany): focus on German industries, EUDAMED/MDR alignment, data enrichment pathways, and experience feedback.

Ackomas operational webinars:

• 23 January 2025 – EUDAMED project: understanding the essentials.
• 30 January 2025 – Entering your data directly in EUDAMED.
• 13 February 2025 – Uploading XML files into EUDAMED.
• 5 June 2025 – Legacy devices: how to ensure EUDAMED compliance (with Efor participation).
• 19 June 2025 – EUDAMED in 2025: what’s at stake for manufacturers? (with SNITEM testimony).
• 25 September 2025 – Medical device labeling: what changes with EUDAMED (special participation from GS1 France).

Replays and resources are available on the Ackomas website.

European Commission workshops attended and relayed:

• 21 May 2025 – Commission workshop in Stuttgart: “onboarding” session to prepare for use of the first four EUDAMED modules.
• 8 October 2025 – Commission workshop in Rome, following the Stuttgart format.
• 3 December 2025 – Commission workshop in Brussels: held after OJEU publication; it generated an exceptional volume of online questions.

Technology and results

• Many MD and IVD manufacturers have chosen Ackomas, a recognized quality and regulatory expert dedicated to the medical device industry worldwide.
• EUDAMED solution operational since 2021: secure M2M integration, quality controls, logging and end-to-end traceability (creations, updates, withdrawals).
• Sustained testing with the Commission’s EUDAMED teams, daily validations, and successful audits.
• Large-scale, error-free publications: consistent customer feedback, reduced publication lead times, and proven production reliability.
• Regulatory and technology monitoring: Ackomas continuously evolves through regular releases, adapts to EUDAMED changes and customer needs, and incorporates requirements from other regulatory databases (GUDID, Swissdamed, SFDA, etc.). This ability to anticipate and adapt ensures sustainable compliance and a solution that stays up to date.

Ecosystem and credibility

Ackomas relies on a strong, recognized ecosystem to reinforce credibility and leadership:

• Strategic partnerships: GS1 Healthcare, MedTech Europe, ISPE, and consulting firms such as EFOR.
• Regulatory expertise: publication of an EUDAMED guide in early 2025, updated after the OJEU publication (November 2025).
• Active presence: trade shows, demos, webinars, LinkedIn articles, and local presence (Spain, Germany, France, DACH).

5) Secure your MDR/IVDR Investments: EUDAMED Publication Is the Last Critical Step

After years of effort to build technical documentation and obtain your Notified Body’s approval, do not overlook regulatory publication in EUDAMED.

In the European Commission’s own words, registering devices in EUDAMED is the only final guarantee of regulatory compliance and access to the European market for the manufacturer.

To turn this obligation into success and avoid noncompliance risks, these are the priority actions to start now.

Your priorities – starting now

• Obtain your SRN (Actors) and clarify responsibilities (manufacturer, authorized representative, importer).
• Map your Basic UDI-DIs.
• Prepare your UDI registrations:
• Data governance (RA/Quality/IT).
• Completeness and format checks.
• Workload planning starting in 2026 (including legacy devices).
• Secure your M2M flows: Ackomas connectors to EUDAMED, pre-upload checks, tracking EUDAMED statuses and notifications.
• Train your teams: use Commission resources, workshops, and Ackomas replays; document your procedures (create, update, withdraw).
• Anticipate certificates: align plans with the NB, track versions, and prepare links between certificates and UDI/Devices.

6) Why So Many Manufacturers Choose Ackomas to Secure Regulatory Publications?

These are not our words, but those of the manufacturers who trust us:

• A solution validated by the European Commission, a strong indicator of compliance and reliability.
• Fast onboarding and tailored support for frictionless implementation.
• M2M automation to avoid the manual dead-end: customers report that after attempting manual entry, they quickly gave up. Continuous processes, team demotivation, risk of resignations… Ackomas removes this burden with automated data flows.
• Built-in quality control: the option to enable a data verification/approval step – not available in EUDAMED – to prevent human error.
• Focus on what matters: with Ackomas, teams do not spend hours handling complex XML files or correcting already compliant data. They focus on exceptions and anomalies – where human value is essential.
• Clear steering and full traceability: completeness indicators, rejections, and lead times to manage compliance in real time.

Customers talk about performance and internal recognition: compliance reached quickly, large-scale publication in EUDAMED production without stress, and teams able to showcase success to executive leadership. Ackomas turns a regulatory obligation into a strategic project – a source of credibility and pride.

Conclusion

The countdown has started: on 28 May 2026, EUDAMED becomes mandatory for the four core modules. This shift is a constraint, but also an opportunity to make your data reliable, your processes controlled, and your market access secure.

Do not let your MDR/IVDR investments be weakened by neglected regulatory publication. The European Commission reiterates it: registration in EUDAMED is the only guarantee of compliance and access to the European market.

With Ackomas, you turn regulatory publication into a controlled process: uncompromising quality, proven reliability, and maximum efficiency, with full traceability and compliance secured.

We know you are the true experts of your devices and your MDR/IVDR compliance. Our role is to make regulatory publication simple and secure for you: a proven solution, robust M2M flows, a clear methodology, and reliable support to save time and reduce risk. No shortcuts: when it comes to compliance, quality is non-negotiable. Ackomas delivers peace of mind and performance at the right cost.

And above all, our customers speak for us: their feedback converges on one essential point – Ackomas delivers reliability, speed, and genuine peace of mind. What was recommended is now mandatory: anticipating with Ackomas means turning a regulatory constraint into a competitive advantage.

(Annex – Sources and milestones cited in this article)

Commission Implementing Decision (EU) 2025/2371 — publication in the Official Journal of the European Union, 27 November 2025.