EU MDCG 2026 Updates on Classification and EMDN Codes

The EU MDCG 2026 updates bring important clarifications to medical device classification under MDR (EU) 2017/745 and revisions to the European Medical Device Nomenclature (EMDN). These changes improve guidance on classification rules, intended use interpretation, and the correct assignment of EMDN codes used in EUDAMED and technical documentation.

Clarifications in Medical Device Classification Guidance (MDCG 2021-24 Rev.1)

The revised MDCG 2021-24 guidance provides the first update to the original 2021 document on medical device classification. While the changes are not major, they strengthen the consistency and usability of MDR classification rules.

Improved Alignment with MDR Terminology

The updated guidance refines wording throughout the document to ensure full consistency with Regulation (EU) 2017/745. This helps reduce ambiguity in interpreting classification rules and improves regulatory harmonization across EU Member States.

Additional Notes and Practical Examples

To support correct application of classification rules, the revision introduces additional notes and examples. These help manufacturers better understand how to apply Annex VIII rules, particularly in more complex or borderline cases.

The examples provide clearer direction on:

• Application of classification rules in real scenarios  

• Interpretation of intended purpose  

• Handling of devices with multiple functions  

Regulatory Impact for Manufacturers

Although the update is incremental, it remains highly relevant because classification directly determines:

• Device risk class (I, IIa, IIb, III)  

• Conformity assessment route  

• Notified body involvement  

Even small clarifications can influence regulatory strategy and approval timelines.

Revisions to EMDN Codes and Annual Maintenance (MDCG 2026 Series)

Alongside classification clarifications, the EU has released the annual revision of the European Medical Device Nomenclature (EMDN), reflected in MDCG 2026-1, 2026-2, and 2026-3.

These documents collectively cover the annual update cycle, including submission outcomes, change logs, and the updated EMDN catalogue.

Key Changes in EMDN Updates

The revised EMDN system includes:

• Introduction of new device codes  

• Updates and corrections to existing codes  

• Removal of outdated entries  

• Structural improvements for better classification consistency  

These updates ensure that the nomenclature remains aligned with technological and regulatory developments.

Importance of Correct EMDN Usage

The EMDN code system plays a critical role in MDR compliance and is required for:

• EUDAMED registration  

• Technical documentation  

• Device traceability across the EU  

Using outdated or incorrect codes can lead to inconsistencies in regulatory submissions and potential delays.

Compliance Actions for Manufacturers

To remain compliant with the latest MDCG updates, manufacturers should:

• Review device classification under the revised MDCG 2021-24 guidance  

• Ensure correct application of MDR Annex VIII rules  

• Verify and update all EMDN codes used in documentation and EUDAMED  

• Align technical files with the latest nomenclature structure  

• Monitor future MDCG revisions for ongoing updates  

Internal Resource

EU Medical Device Classification & Regulation (MDR/IVDR)

External Resources

• MDCG 2021-24 Rev.1 (Classification Guidance)
  

• MDCG 2026-1 (EMDN Submissions Summary)
  

• MDCG 2026-2 (Change Log)
  

• MDCG 2026-3 (EMDN Catalogue)

‍