MedTech Europe Publishes Practical Guide for Using the European Medical Device Nomenclature (EMDN)
MedTech Europe has published a practical guide to support manufacturers of medical devices and in vitro diagnostic devices (IVDs) in correctly applying the European Medical Device Nomenclature (EMDN) — a key element for compliance with Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
The main purpose of this document is to promote a coherent and harmonised application of the EMDN , in particular in the context of device registration in the EUDAMED UDI module and in the regulatory use of the nomenclature.
What does the guide cover?
The guide offers practical guidance on:
How to identify and assign the most appropriate EMDN code to each device, based on its structural and functional characteristics;
How to use EMDN in regulatory documents and sampling processes, as per MDCG 2019-13 guidance;
How to register devices, systems and sets of procedures in the EUDAMED UDI module;
How to submit proposals for new codes in the annual nomenclature update process.
An essential tool for consistency and traceability
Using concrete examples, the guide helps users to:
Identify analogous or similar devices for registration, certification or sampling purposes;
Ensure correct data aggregation in the European database ;
Use the most terminal level of code whenever possible, promoting accuracy in classification.
Good practices for situations where no suitable code exists (the provisional use of code “99” is recommended) and clear instructions on how to submit suggestions for new codes to the European Commission are also included.
Smart MDR Support
Correct use of EMDN is essential for:
Effective submission to EUDAMED ;
Demonstration of regulatory compliance before authorities and Notified Bodies;
Harmonization of technical documentation with European requirements.
The Smart MDR team is prepared to support manufacturers and legal representatives in the application of the EMDN , whether in structuring technical documentation, submitting devices to EUDAMED, or in the overall regulatory strategy.
Contact us to ensure your devices are correctly classified and ready for the European market.
Be Smart. Be Compliant.
