MDCG 2026-1: EMDN Updates from 2025 Public Consultation Published
The Medical Device Coordination Group (MDCG) has published MDCG 2026-1, presenting the outcome of the 2025 public consultation on the European Medical Device Nomenclature (EMDN) and the work of the MDCG Nomenclature Working Group.
The document summarises submitted requests and their evaluation results, classified as:
Accepted
Partially accepted
Not accepted
Partially accepted requests include cases where a proposal was accepted but not at the level originally requested.
Requests were not accepted where, for example:
insufficient information or technical details were provided,
the request duplicated an existing level,
or the proposal was not compliant with the EMDN structure.
Not Accepted Submissions
The document provides detailed examples of requests that were not accepted.
A large number of submissions were rejected due to insufficient technical information, including requests related to:
needles and administration devices,
IVD instruments and reagents,
hearing aid software,
measuring devices and accessories.
Other requests were not accepted because they were:
out of scope of the EMDN update,
related to devices not yet placed on the EU market,
or requiring structural changes not feasible within the current nomenclature.
Examples include:
proposals to align categories with ISO 9999,
requests involving devices under development or without confirmed conformity assessment,
and requests for general clarification on EMDN management.
Accepted and Partially Accepted Submissions
Updates resulting from accepted and partially accepted requests are presented using:
green for added levels,
red for deleted levels,
light blue for updated terms.
Selected Accepted Updates
A new section for neurovascular angiography devices has been added under code C0104, including diagnostic and therapeutic sublevels.
Updates to hearing implant terminology include:
renaming of existing terms,
and insertion of J0304 Bone Conduction Implants.
A new code has been introduced for liquid crystal body temperature indicators (V03010105).
New codes have been added under patient handling equipment, including patient transfer sheets and mattresses.
A new section has been created for vital signs telemetry instruments under monitoring devices.
Selected Partially Accepted Updates
Requests for medical transfer needles were partially accepted and integrated into existing structures.
Requests related to medical tube connectors were partially accepted within existing connector categories.
Requests for robotic surgery trocars and instruments resulted in additions within existing nomenclature levels.
Requests related to endobronchial tubes and blockers were partially accepted and incorporated into existing classifications.
Updates to digital thermometers, including contact thermometers with probes, were partially accepted within existing structures.
Requests for new categories in urogenital devices for sexual dysfunction were partially accepted at a broader level.
Requests related to IVD markers such as presepsin (sCD14) were partially accepted and included under specific protein classifications.
Additional Updates
Further updates include:
revision of terminology for dental restorative composites,
restructuring of dental imaging equipment categories,
updates to blood product thawing devices,
and reorganisation of telemetry instrument classifications.
Conclusion
MDCG 2026-1 provides a detailed overview of the evaluation of EMDN update requests submitted during the 2025 public consultation, including accepted, partially accepted, and rejected proposals, together with the corresponding justifications.
Read the full document below.
