Swissmedic Publishes User Guide for the swissdamed UDI Devices Module
Swissmedic has published Version 3.0 of the swissdamed User Guide – UDI Devices Module, providing instructions for the registration and management of medical devices within the swissdamed system.
The updated guide includes new chapters covering Machine-to-Machine (M2M) registration, manual creation and management of UDI-DIs through the online editor, and guidance relating to the Master UDI-DI.
New Functionality for UDI-DI Management
The guide describes the processes available for creating, editing and managing UDI-DIs within the UDI Devices module.
According to Swissmedic, UDI-DIs can be edited when they are in the following statuses:
Draft;
On the market;
No longer placed on the market.
Changes remain subject to the non-updatable fields defined in the Data Dictionary.
The document also explains that devices saved without submission remain available under Manage UDI-DIs in progress, allowing users to continue editing and complete the process at a later stage.
Introduction of the Master UDI-DI
One of the key additions in Version 3.0 is the inclusion of detailed guidance relating to the Master UDI-DI.
According to Swissmedic, certain highly individualised devices require a Master UDI-DI, including:
Standard soft contact lenses;
Rigid gas permeable contact lenses;
Made-to-order soft contact lenses;
Made-to-order rigid gas permeable contact lenses;
Spectacle frames;
Spectacle lenses;
Ready-to-wear reading spectacles.
Registration Timelines for Master UDI-DI
The guide establishes implementation dates for the registration of these devices within swissdamed.
According to the document:
Contact lenses must be registered using a Master UDI-DI from 9 November 2026;
Spectacle frames, spectacle lenses and ready-to-wear reading spectacles must be registered using a Master UDI-DI from 1 November 2028.
Available Submission Methods
Swissmedic states that Master UDI-DIs may be uploaded by:
Swiss manufacturers;
Authorised representatives;
Foreign manufacturers holding a mandate.
Submissions may be completed through:
XML file uploads;
Machine-to-Machine (M2M) integration;
Manual entry through the online editor.
A UDI Editor user role is required for uploading these records.
Requirements for Issuing Entities
The guide also outlines the requirements applicable to Master UDI-DI issuing entities.
According to Swissmedic, the following issuing entities are accepted:
GS1;
HIBCC;
IFA.
The document further clarifies that ICCBBA is not accepted as a Master UDI-DI issuing entity because it does not assign Master UDI-DIs.
Relevance for Medical Device and IVD Manufacturers
The guide is particularly relevant for medical device and IVD manufacturers placing products on the Swiss market and preparing to meet Swiss UDI requirements.
Topics of interest include:
UDI-DI registration in swissdamed;
Manual management of device identifiers;
Machine-to-Machine (M2M) integration;
Master UDI-DI requirements;
Implementation timelines for specific device categories;
Device data management within the Swiss regulatory system.
The publication provides practical guidance to support organisations preparing their UDI registration and device data management processes as swissdamed continues to evolve.
