The MDCG has released a guidance document concerning EMDN codes. This document is split into three main sections and provides an overview of the actors involved in the generation and maintenance of the EMDN codes and lays out the procedures for the annual revision of the EMDN Codes as well as the procedure for ad-hoc requests requiring an expedited review.
Actors Involved
The first part of the document provides an overview of the EMDN actors that will be involved in the creation and maintenance of the EMDN codes. They involve the following entities:
- MDCG Nomenclature working group.
- EMDN-TT
- Users
Procedure for the annual revision of the EMDN
The relevant actors can request new EMDN codes at any time during the year, that being said, the EMDN technical team will only review the requests once per year. The annual revisions of the EMDN will proceed by means of four phases split over the duration of a year. During each phase, different tasks and objectives are undertaken by different actors. The document highlights the four main phases which are.
- Phase I – Collection Requests
- Phase II- Evaluation of the requests and analysis of the practical use
- Phase III – Validation and endorsement
- Phase IV – MDCG endorsement and publication
Pilot procedure for the ad-hoc updates of the EMDN requiring an expedited review
The guidance document stresses the fact that the annual procedure mentioned above is the standard procedure. That being said, they are piloting a procedure for ad-hoc requests.
For the request to be eligible for the ad-hoc procedure, certain criteria must be satisfied. These include:
- The request must be submitted by the competent authority or notified body
- Only new code requests may be submitted.
- A Justification is required.
The document can be accessed using the following link
