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How Product Packaging in Portugal is Affected by latest EU MDR Language Updates
Content Manager

The EU MDR continues to evolve and so do its implications for labeling and artwork. The European Commission’s latest update (August 2025) revises national EU MDR labeling requirements, this time focusing on Portugal. While this may seem like a small change, it highlights a much bigger challenge for global manufacturers: keeping pace with shifting, country-specific rules across Europe.


What’s Changed in The Latest EU MDR Update?


  • Portugal now requires Portuguese for all core documentation, including labels, IFUs, and implant cards.


  • English may still be used for professional users or GUI interfaces, but only under strict conditions:

              - Portuguese IFUs must still be available (including translations of any GUI 
                 content).

              - No evidence of incidents or complaints linked to English-only usage can 
                 exist.


This follows earlier updates for France (2024) and Romania (2024), demonstrating that EU MDR regulations, particularly around language, are constantly being refined.


What Do Manufacturers Need to Do 


For manufacturers, this isn’t just a translation issue, but a compliance and risk management challenge:
 

  • Multiple regimes to track: Each EU Member State can enforce its own language rules under EU MDR regulations.
  • Digital touchpoints included: GUIs, apps, and digital instructions are all subject to EU MDR labeling requirements.
  • Risk of non-compliance: Missteps can mean rejected submissions, product recalls, or reputational damage.

In practice, this means labeling and artwork processes must go beyond static packaging — they need to be dynamic, multi-language, and fully auditable.


How Kallik's Cloud-Based, End-to-End Labeling and Artwork Software Can Help


Kallik’s Veraciti is designed for exactly this type of regulatory complexity. By providing a centralized source of truth for all label content across countries and languages, it ensures consistency and control. Its automated workflows apply country-specific EU MDR labeling requirements directly to artwork, labels, IFUs, and GUIs, removing the risk of manual error. At the same time, Veraciti delivers audit-ready compliance with full version control and traceability for every language update, giving manufacturers the confidence that nothing is overlooked. And when national provisions shift under EU MDR regulations, Veraciti enables fast, accurate updates across entire product portfolios, allowing companies to stay ahead of change rather than scrambling to catch up.

The EU MDR will continue to evolve, and language requirements are just one piece of the puzzle. As more countries refine their expectations, organizations without a robust system will face rising costs, slower approvals, and higher compliance risks. With Veraciti, you don’t just react to new and updated regulations; you stay one step ahead. 


Want to Know More About the Leading Labeling and Artwork Software Recommended by Gartner?


Here at Kallik, our experts are here to help businesses stay ahead of the curve, building labeling and artwork processes that are agile, compliant, and future-ready. Get in touch with us today by emailing enquiries@kallik.com or calling +44 (0) 1827 318100. Alternatively, click here to contact us and see what our software can do for your business. Want to stay up to date with all the latest industry news to keep ahead of regulatory changes? Scroll to the bottom to sign up for our bi-monthly newsletter to get all the info you need, directly in your inbox!