Swissmedic Publishes Version 2.0 of the swissdamed UDI Data Dictionary
Swissmedic has published Version 2.0 of the UDI Data Dictionary for the swissdamed system, updating the technical documentation that defines the data elements used within the UDI Devices module for the registration of medical devices in Switzerland.
The document describes the data fields, formatting rules, update requirements and mappings with corresponding EUDAMED data elements, supporting manufacturers and other economic operators in preparing and maintaining UDI information throughout the device lifecycle.
Updated UDI Data Requirements
The Data Dictionary provides detailed specifications for the data elements required to register medical devices within swissdamed.
Among the topics covered are:
Mandatory and optional data fields;
Data types and formatting requirements;
Record update rules;
Mapping between swissdamed and EUDAMED data elements;
XML and JSON structures used for electronic submissions.
New Data Elements Introduced
Version 2.0 includes additional requirements relating to several categories of device information.
The updated Data Dictionary introduces or expands guidance on:
Clinical sizes;
CMR substances;
Endocrine-disrupting substances;
Substances that, if used separately, may be considered medicinal products or human blood/plasma derivatives;
Original manufacturer information.
UDI Identifier and Packaging Information
The document also provides detailed requirements for managing packaging information and UDI identifiers within swissdamed.
Topics addressed include:
Package UDI-DI;
UDI hierarchy;
Device quantity per packaging level;
Issuing entities;
Device market status.
Alignment with EUDAMED
According to Swissmedic, many of the data elements included in swissdamed follow the same structure as those used in EUDAMED, supporting greater consistency across regulatory systems.
The document provides mappings between swissdamed and EUDAMED fields, including references to XML schemas, JSON attributes and validation rules applicable to electronic submissions.
Relevance for Medical Device and IVD Manufacturers
The updated Data Dictionary is particularly relevant for medical device and IVD manufacturers, as well as other economic operators responsible for registering devices on the Swiss market.
Topics of particular interest include:
UDI data requirements;
Device registration in swissdamed;
XML and JSON submission structures;
Alignment with EUDAMED;
UDI identifier management;
Regulatory data quality and consistency.
The publication provides practical technical guidance to help organisations prepare UDI submissions and manage regulatory data as the swissdamed system continues to evolve.
