MDCG Publishes Revision 2 of EMDN Guidance (MDCG 2021-12 Rev.2)

In April 2026, the Medical Device Coordination Group (MDCG) published Revision 2 of MDCG 2021-12, providing updated FAQs on the European Medical Device Nomenclature (EMDN) .

The document clarifies the use, structure, and maintenance of EMDN under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

Role of EMDN

According to the MDCG document, the EMDN:

• Supports the functioning of EUDAMED

• Is used by manufacturers for device registration, linked to the UDI-DI

• Is used in:

  • Technical documentation

  • Notified Body sampling

  • Post-market surveillance

  • Vigilance and post-market data analysis

The nomenclature is available free of charge and accessible to all stakeholders.

Structure of the nomenclature

The EMDN is based on a seven-level hierarchical structure, including:

• Categories (first level)

• Groups (second level)

• Types (third level and further sublevels)

Each code is alphanumeric and linked to a term describing the device.

EMDN code assignment

The document states that manufacturers:

• Must assign the most granular (lowest-level) code available

• Should assign one code per UDI-DI, unless multiple intended purposes apply

Where no appropriate code exists, the code extension “99 – Other” may be used.

Code extensions “90” and “99”

The MDCG clarifies that:

• “99 – Other” represents a terminal level and may be used for UDI-DI assignment

• “90 – Various” is not a terminal level and cannot be used for UDI-DI registration

Multiple EMDN codes

Multiple codes may be assigned in specific cases, including:

• Devices with multiple intended purposes

• Devices falling under Category X (Annex XVI products without an intended medical purpose)

• Devices with both medical and non-medical intended purposes

No prioritisation between assigned codes is required.

Annual update procedure

The MDCG describes an annual EMDN update process, including:

• Publication of updates on the European Commission website

• Availability of documentation describing changes compared to previous versions

• No direct notification to users on implemented changes

A 15 working day deadline is established for responding to clarification requests during the review process.

Obsolete and split codes

The document specifies that:

• Obsolete codes remain visible in EUDAMED for at least 5 years, but cannot be used for new registrations or updates

• Split codes remain visible but are no longer available for registration

• Archives of obsolete and split codes are maintained and made publicly available

Updates to registrations and documentation

Manufacturers and notified bodies are expected to:

• Reflect EMDN changes in:

  • EUDAMED registrations

  • Certificates

  • Declarations of Conformity

• Implement updates at the latest before the next annual surveillance audit following the update cycle

Read the full document below.