New symbols in medical device labeling: what changes in 2026

Key data

Medical device manufacturers operating in Europe have a new obligation to review documentation and labeling. The European Commission has published Implementing Decision (EU) 2026/1313, which updates the reference to the harmonized standard EN ISO 15223 on the symbols used in labels, instructions for use and informational documentation of medical devices. This decision modifies the previous Implementing Decision (EU) 2021/1195, which is replaced with respect to this specific standard.

The impact is significant: whoever does not adapt their materials to the updated version of the standard will lose the presumption of conformity with the Regulation (EU) 2017/745, the main regulatory framework for the sector. And without that presumption, marketing in the European single market is at risk.

What does this regulation establish?

The harmonized standard EN ISO 15223 defines the graphic symbols that must appear on the labels of medical devices: temperature icons, expiration date, batch number, manufacturer, single use, etc. These are the symbols that any healthcare professional or user recognizes on a medical device.

The Commission periodically updates references to these standards to reflect technical revisions by ISO and CEN. With this decision, the valid reference becomes the updated version of EN ISO 15223, with the previous version referenced in Decision 2021/1195 no longer conferring presumption of conformity.

There is a transitional period during which both versions can coexist. After that period, only the new version will grant presumption of conformity. The exact duration of the transitional period is not specified in the published data: it must be consulted in the full text of the decision.

Economic and operational impact

The direct impact is fundamentally operational and compliance-related, with costs associated with reviewing and updating materials. Affected companies must assess:

• Review of physical labels: redesign, validation and reprinting of product labels to incorporate the updated symbols according to the new version of EN ISO 15223.
• Update of instructions for use (IFU): all accompanying documents that include standardized symbols must be reviewed.
• Update of informational materials: catalogs, technical datasheets and sales documentation that reference or reproduce symbols from the standard.
• Review of the technical file: the technical file documentation under Regulation (EU) 2017/745 must reflect compliance with the updated standard.
• Risk of commercial blockade: without presumption of conformity, products may face obstacles in audits by notified bodies or in market controls.

The cost varies greatly depending on the size of the product catalog and the complexity of labeling. For manufacturers with dozens or hundreds of product references, the review effort can be significant. For distributors and importers, the main risk is receiving products from third parties that have not yet updated their labels.

Who does it affect?

• Medical device manufacturers based in or marketing in the EU: obligated to update labels, IFU and technical file.
• Importers of medical devices from third countries: must verify that products they introduce to the European market comply with the new version of the standard.
• Distributors of medical devices in the EU: must ensure that products they market have compliant labeling before putting them on sale.
• Notified bodies that audit the conformity of medical devices under Regulation (EU) 2017/745.
• Regulatory managers (RA Managers) and quality departments of companies in the sector.

Practical example

A Spanish manufacturer of wound care materials (dressings, bandages, single-use instruments) with 50 product references in the European market must, before the transitional period expires:

1. Review each of its 50 label sheets to identify which symbols come from EN ISO 15223 and whether they have changed in the updated version.
2. Update the label design files and validate the changes with its regulatory department.
3. Reprint the labels or coordinate with its packaging supplier to change the final artwork.
4. Update the instructions for use (IFU) for each affected reference.
5. Document the entire process in the technical file so it is accredited before the notified body.

If this manufacturer also exports through a distributor in Germany or France, it must notify them of the change so they do not market stock with obsolete labeling once the transitional period expires.

What should companies do now?

1. Identify the exact transitional period: consult the full text of Decision 2026/1313 to know the deadline by which the previous version of EN ISO 15223 ceases to grant presumption of conformity.
2. Audit the product catalog: list all references that include EN ISO 15223 symbols in labels, IFU or informational materials.
3. Compare versions of the standard: acquire or access the new version of EN ISO 15223 and compare the modified symbols with respect to the previous version.
4. Update label design and IFU: incorporate the updated symbols and validate the changes with the regulatory and quality team.
5. Update the technical file: document compliance with the new version of the standard in the technical documentation under Regulation (EU) 2017/745.
6. Communicate to the distribution chain: inform importers and distributors of the change to prevent them from marketing products with non-compliant labeling after the transitional period.
7. Coordinate with the notified body: if the product requires notified body intervention, inform them of the change and verify if certification update is required.

Official source

Consult complete regulation in official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601313