New Template Available: Notified Body Transfer Agreement for Surveillance of IVDD Legacy Devices
11 September 2024
Update on Swiss Parliament’s 2022 Vote to Accept US FDA Devices onto the Market
26 September 2024The EMDN Working Group published the minutes from their July 2024 meeting. They are available: HERE
Overview
The Working Group outlined the upcoming actions to be taken by the end of 2024:
- First training event will occur; note, this appears to be limited to stakeholder associations and competent authorities, with limited seating capacity
- A dedicated platform will be activated, where “users can submit questions about EMDN structure, and manufacturers can access relevant information to help choose appropriate codes for MDR/IVDR”
- First release of the glossary is complete and the first version of the EMDN definition will be released
- The FAQ on EMDN has been provisionally endorsed and will be circulated for review/major concerns
- Long-term project is underway to update all terms and definitions, with a significant focus on this during the EMDN Working Group’s November 2024 meeting
As outlined in MDCG 2024-2, industry may request new EMDN codes as needed. The update for the 2024 submissions is:
- 51 requests were submitted
- 45 are under current assessment
- Four were not accepted due to insufficient information provided by the users and two were not accepted because they were duplicate submissions
- For 19 of the 51 requests, additional information was requested from the users, highlighting the need for training on best practices for submitting a sufficient level of detail
Update on Annex XVI devices:
- How to handle devices that have multiple intended purposes or dual use, e.g., non-medical under Annex XVI and medical?
- The Working Group advised that it is possible to associate the same UDI/DI to different codes in EUDAMED, i.e., devices may be registered multiple times under different EMDN codes and terms.
- The endorsed Annex XVI EMDN proposal was sent to the Annex XVI Working Group
Translation of EMDN codes:
- A budget has been approved to translate the 7,000+ codes into the 23 official languages
The WHO’s MeDevIS Platform
The WHO presented an update on Version 1 of its medical device information system (MeDevIS), which currently includes the EMDN codes for 2301 devices. It is available: HERE
MeDevIS is a centralized system for medical device information and provides a harmonized naming system. It contains both EMDN and GMDN codes within the device details and will be continually updated. This makes it a very useful resource for manufacturers attempting to map their GMDN code to their EMDN code. A sample entry from MeDevIS is provided for reference below.
