[OCTIKA] Eudamed & UDI: how to turn a regulatory constraint into a lever for efficiency

Collaboration between Octika eyewear and Made In Tracker, with human and technical support from EasyUDI

The gradual implementation of EUDAMED and the strengthening of UDI requirements have profoundly changed the daily lives of medical device manufacturers.

Creating UDI codes, generating compliant labels, declarations of conformity, structuring product data... For many companies, these new obligations represent:

• A significant administrative burden

• A rapid increase in skills required

• A significant risk of error

• Increased pressure on quality and regulatory teams

The difficulty lies not only in the regulation itself, but in its operational implementation.

When EUDAMED regulations become an organizational challenge

This was precisely the situation Octika faced when it came to addressing the requirements of EUDAMED and UDI codes.

Like many players in the sector, the company did not yet fully understand these new obligations at the outset. The regulatory framework was evolving rapidly, expectations were becoming clearer, and it was becoming necessary to secure processes.

Their priorities: To be compliant—without disrupting their internal structure!

1. Create and generate UDI labels

   

   
   

   

2. Register the catalog of frames in EUDAMED

   1. Find the entire catalog already registered in the European database.

      

      

      

      Tabular view of the frame registry for Octika Eyewear, extracted from EUDAMED (the European database for medical devices)

      
      

3. Centralize the management of GS1 data, production data, frame references, and connection to the Eudamed portal in one place.

   

   EasyView: the entire Octika catalog registered in Eudamed, displayed in clear views tailored to each use: hierarchical tree structure, spreadsheet view, or time-stamped audit log.

4. Ready for Master UDI

   1. According to the guide MDCG 2025-8 (november 2025)

      Guidelines for implementing the core UDI-DI solution for eyeglass frames, eyeglass lenses, and ready-to-wear reading glasses

      

5. Preparation of the Declaration of Conformity

   

   Example of a declaration of conformity

A human support above all

Rather than managing this complex transition alone, the Octika teams chose to collaborate on their project with Made in Tracker for the listing of their products on EUDAMED.

A truly turnkey solution with regular follow-up.

Progress interface in the support process for submitting and recording data in Eudamed

This is their feedback:

“We work with Made in Tracker to list our products on EUDAMED, particularly for creating UDI codes and labels. As we were unfamiliar with these new regulatory requirements at the outset, we particularly appreciated their clear and reassuring support. Their team was informative, available, and perfectly suited to our organization.”

This testimony highlights an essential point: In a demanding regulatory environment, the tool alone is not enough. Support makes all the difference.

A platform designed to simplify

Beyond human expertise, the technological solution made the difference.

The EasyUDI platform enabled Octika to:

• Easily generate UDI codes

• Create compliant labels

• Centralize product data

• Produce its declaration of conformity

• Secure its listing on EUDAMED

As they explain:

“The intuitive platform makes it easy to generate labels and declarations of conformity, which saves a lot of time.”

In an environment where rigor is essential, simplicity becomes a strategic asset.

The result: time-saving and peace of mind:

The concrete impact for Octika:

• Rapid skills development

• Reduced compliance-related stress

• Significant time savings

• Improved internal organization

And above all, the certainty of being supported by a committed partner.

They conclude:

“We recommend EasyUDI to any optical company looking for a reliable and committed partner.”

Compliance and performance are not incompatible

Octika's experience illustrates a reality in the medical sector: regulatory compliance is no longer just an obligation. It is becoming a key factor in industrial performance.

When properly supported and equipped, it enables:

• Secure product development

• Smoother internal processes

• Anticipation of regulatory changes

• Strengthened credibility in the European market

What about you?

Is your organization ready for EUDAMED and UDI requirements? Do you have a tool that is truly suited to your structure?

At Made in Tracker, our goal is clear: to transform regulatory complexity into a controlled and efficient process.

👉 Find out how EasyUDI can help you achieve compliance with complete peace of mind.