EU IVDR Nomenclature and Traceability: Articles 22-23 and the EMDN

1. Key takeaways

Article 22 requires economic operators to identify devices within the supply chain and to cooperate with competent authorities and notified bodies to achieve traceability. Article 23 requires that the information submitted be expressed using the medical device nomenclature, in order to support the data interoperability of EUDAMED. The nomenclature currently in use in the Union is the EMDN, the European Medical Device Nomenclature; the relevant procedures and update rules are described in MDCG 2021-12 Rev.1 and MDCG 2024-2 Rev.1.

Together, these two provisions complete the identification layer of the Regulation: Article 22 governs who must identify what within the supply chain, while Article 23 governs the common vocabulary with which that identification is expressed in the European database. Devices that are properly identified but described with inconsistent vocabulary remain invisible to data aggregation, so both obligations must be operated in parallel.

2. Legal basis

3. Expert insights

Insight 1: The nomenclature is infrastructure for data interoperability, not a classification tool.

Article 23 sits in Chapter III of the Regulation, whose title addresses the identification and traceability of devices, the registration of devices and of economic operators, the summary of safety and performance and the European database on medical devices. Within that framework, the nomenclature exists so that different Member States and different systems use the same terms for the same type of device. It does not alter the classification outcome under Annex VIII: classification follows risk, while the nomenclature follows terminology. Teams sometimes try to reverse-engineer a classification decision from an EMDN code or to justify a class assignment with a nomenclature term, and this is a category error. The two systems answer different questions, and documentation should keep them separate.

Insight 2: EMDN codes are adjusted as technology evolves, which requires version management.

MDCG 2024-2 Rev.1 sets out the procedure for updating the EMDN, and MDCG 2021-12 Rev.1 answers frequently asked questions about its use. After a company has submitted its records to EUDAMED, it must keep tracking code updates, and when the data structure changes it should review the records already submitted, so that old and new codes do not coexist for the same device family and distort the statistical picture. A practical implementation is a version tracking table that records, for each device entry, the code in use, the date of selection, the version of the nomenclature it comes from, and the review status after each nomenclature update. This table becomes the single source of truth for every registration record downstream.

Insight 3: The traceability duty of Article 22 and the UDI are two legs of one system.

Article 22 deals with identification and cooperation within the supply chain; the UDI of Article 24 provides the machine-readable identification carriers. Article 24(8) requires economic operators to keep records of the UDIs of the devices they have supplied or received, for the classes or groups of devices determined by the measures adopted under Article 24(11)(a), and Article 24(9) encourages, or allows Member States to require, health institutions and healthcare professionals to keep such records. The two mechanisms reinforce each other: supply chain identification makes devices traceable in business terms, while the UDI makes them traceable in data terms. Organisations should maintain separate ledgers for the two, one for identification information under Article 22 and one for UDI record-keeping under Article 24(8), while ensuring the two ledgers reference the same device entries.

Insight 4: Nomenclature errors are directly exposed in market surveillance.

Part of the data held in EUDAMED is publicly accessible, such as the economic operator data under Article 28(7), the certificate status under Article 51(5) and the SSP under Article 29(1). Nomenclature entries submitted with errors are therefore visible to purchasers, competitors and competent authorities, and inaccurate records can trigger the evaluation procedure of Article 89. The reputational and commercial consequences of a wrong code reach further than the database itself: tender documents, product comparisons and surveillance planning all draw on the registered data. Verification of nomenclature entries before submission is thus a quality task, not a typing task, and it belongs in the same review chain as the technical documentation.

4. Practical recommendations

1. Determine the EMDN code for every device entry and retain the selection rationale together with the version date, so that the choice can be defended and reproduced in later reviews.
2. Set up an EMDN version tracking table, and review the records already submitted to EUDAMED after each nomenclature update under MDCG 2024-2 Rev.1.
3. Establish separate ledgers for supply chain identification under Article 22 and for UDI record-keeping under Article 24(8), referencing the same device entries.
4. Before submitting to EUDAMED, run a three-way consistency check across nomenclature, classification and UDI, confirming that the code, the risk class and the identifiers describe the same device in the same terms.
5. Bring nomenclature and UDI data under change management, so that added variants or changed intended purposes update both systems in the same pass.

5. Verification checklist

• □ An EMDN code has been selected for every device entry, with the rationale and version date recorded
• □ An EMDN update tracking mechanism has been established under MDCG 2024-2 Rev.1
• □ A supply chain identification ledger has been established under Article 22
• □ UDI record-keeping obligations have been implemented for economic operators under Article 24(8)
• □ The three-way consistency check across nomenclature, classification and UDI has been completed
• □ Nomenclature and UDI data have been incorporated into change management

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with nomenclature and traceability compliance under the IVDR: EMDN code selection and rationale documentation, version tracking against MDCG 2024-2 Rev.1, supply chain identification ledgers under Article 22, and consistency checks across nomenclature, classification and UDI before EUDAMED submission. Contact us at info@grzanglobal.com to review your nomenclature data.

Legal information verified as of 29 October 2026.