Drugdu.com expert's response:

The European Medical Device Nomenclature (EMDN) is a naming system established by the European Commission to support the operation of the European Database on Medical Devices (EUDAMED). Below is a detailed introduction to EMDN:

I. Background and Purpose

Background: In accordance with Article 26 of the Medical Devices Regulation (MDR) (2017/745) and Article 23 of the In Vitro Diagnostic Medical Devices Regulation (IVDR) (2017/746), the European Commission decided to establish the EMDN system.

Purpose: EMDN aims to support the regulatory requirements of MDR and IVDR, including the preparation of device and technical documentation, sampling audits of technical documentation by notified bodies, post-market surveillance, vigilance, and post-market data analysis. It also provides patients with key descriptions of medical devices that have been marketed and registered in EUDAMED.

II. Structure and Composition

Structure: The alphanumeric structure of EMDN is based on a seven-level hierarchy, but typically, a simplified three-level structure (category, group, type) is used, with the option to expand to finer levels when necessary.

Composition: Each EMDN code begins with an uppercase English letter indicating the "category" of the device (e.g., W for in vitro diagnostic devices). It is followed by two digits representing the "group" and a series of digits representing the "type". The maximum number of digits is set at 13.

III. Application and Function

Application: Manufacturers should assign an EMDN code to each medical device when registering it in the EUDAMED database and associate it with each Unique Device Identifier (UDI-DI).

Function: EMDN plays a crucial role in CE technical documentation, sampling audits of technical documentation, post-market surveillance, and other processes. It helps regulatory authorities, manufacturers, and other stakeholders communicate medical device information more effectively and supports patient safety.

IV. Characteristics and Advantages

Standardization: EMDN provides a standardized naming framework that enables similar or identical types of medical devices produced by different manufacturers to be uniformly identified and classified.

Transparency: Through EMDN, patients and the public can more easily access key information about medical devices, improving the transparency and traceability of medical equipment.

Efficiency: The use of EMDN simplifies the registration and regulatory processes for medical devices, enhancing the efficiency of regulatory authorities.

V. Relationship with GMDN

GMDN: The Global Medical Device Nomenclature (GMDN) is a directory used to identify the common names of all medical device products. GMDN codes are developed according to ISO 15225 and are widely used in international medical device regulatory fields.

Relationship: Although EMDN and GMDN are mapped to some extent, they differ in drafting scope, application scenarios, and recognition levels in jurisdictions. The drafting scope of EMDN terms is broader than that of GMDN terms, so one EMDN term may cover multiple types of medical devices. Meanwhile, most members of the International Medical Device Regulators Forum (IMDRF) use GMDN, while EMDN is a unique naming system for the European Union.

In summary, the European Medical Device Nomenclature (EMDN) is a standardized naming system established by the European Union to support medical device regulation. It features a clear structure, wide application, and a high degree of standardization, playing an important role in the registration, regulation, and patient safety of medical devices.