Swissmedic Updates swissdamed Business Rules to Version 5.0
Swissmedic has updated its technical document “swissdamed Business Rules” to version 5.0, valid from 2 September 2026.
The document, identified as BW630_40_002, contains the business rules for swissdamed.
Purpose of the Document
Swissmedic explains that the purpose of the document is to provide the business rules for swissdamed.
These rules define the conditions that must be fulfilled to provide correct data to swissdamed. The document also indicates corresponding EUDAMED business rules in brackets after the swissdamed rules, where applicable, to establish a link between EUDAMED and swissdamed.
Scope
The business rules are structured similarly to the corresponding EUDAMED business rules.
Swissmedic notes that current business rules may already cover or include future functionality, while additional rules may be added later to fully cover the relevant functionality.
Key swissdamed Business Rules
The document includes general swissdamed rules on UDI-related data.
These include requirements that private address details are ignored by swissdamed, that the type of UDI-PI is mandatory when submitting a UDI-DI under MDR or IVDR, and that the base quantity of device is mandatory for UDI-DI submissions under MDR and IVDR, except for system or procedure packs.
Swissmedic also states that reprocessing of single-use devices is prohibited in Switzerland and Liechtenstein, meaning such devices cannot be uploaded to swissdamed.
Registration of Basic UDI-DI and UDI-DI
The document explains that UDI Editors of manufacturers, or manufacturer mandates, can register Basic UDI-DIs, EUDAMED DIs, Master UDI-DIs, UDI-DIs and EUDAMED IDs for applicable legislation including MDR, IVDR, MDD, AIMDD and IVDD.
UDI Editors of persons who assemble systems or procedure packs, or their mandates, can register Basic UDI-DIs and UDI-DIs under MDR for system or procedure packs.
The rules also define uniqueness requirements for device identifier codes, including Basic UDI-DI, Master UDI-DI, Secondary UDI-DI, Package UDI-DI and EUDAMED DI codes.
Mandatory and Conditional UDI Data
Swissmedic states that submitting a new Basic UDI-DI always requires an associated UDI-DI with all its attributes.
The document also addresses Secondary UDI-DI, Unit of Use DI, maximum number of reuses, CMR substance information, endocrine-disrupting substances, storage and handling conditions, critical warnings and contraindications.
For device model or device name, at least one of the two is required when registering a new Basic UDI-DI. Several UDI-DIs can be associated with the same Basic UDI-DI, but each UDI-DI must be linked to one and only one Basic UDI-DI.
Market Status
The document clarifies that newly uploaded Master UDI-DIs, UDI-DIs or EUDAMED IDs are initially set to draft status by default.
Draft identifiers can be set to “On the market” or deleted. The status “No longer placed on the market” can be set subsequently. If no market status is assigned within 30 days of upload, the identifier is automatically deleted from swissdamed.
Nomenclature, Legislation and Risk Class
Swissmedic states that nomenclature codes for a UDI-DI must be selected from the EMDN nomenclature list published by the European Commission.
Only a leaf code, meaning the lowest level within the nomenclature branch, can be submitted, and at least one valid nomenclature code is mandatory for a UDI-DI.
The document also specifies that a device can have only one applicable legislation. Regulation devices may fall under MDR or IVDR, while legacy devices may fall under MDD, AIMDD or IVDD. Devices must also be assigned a risk class corresponding to the legislation under which they fall.
Master UDI-DI
The rules explain that Master UDI-DI is applicable only under Regulation (EU) 2017/745.
Special device types requiring registration of a Master UDI-DI include standard and made-to-order soft contact lenses, standard and made-to-order rigid gas permeable contact lenses, spectacle frames, spectacle lenses and ready-made reading spectacles.
The document also states that Master UDI-DIs for spectacles cannot be registered in swissdamed before the format has been defined by the issuing entities.
Legacy Devices
For legacy devices, Swissmedic defines identification elements such as EUDAMED DI, equivalent to Basic UDI-DI, and either UDI-DI or EUDAMED ID, depending on whether a previously assigned UDI-DI exists.
If a legacy device already has a UDI-DI, the EUDAMED DI is generated based on that UDI-DI. If not, the manufacturer must provide the EUDAMED DI using a specific format, and the EUDAMED ID is generated based on the EUDAMED DI.
Managing Devices and Certificates
The business rules describe how uploaded devices without assigned market status may be manually deleted or automatically deleted within 30 days of upload.
They also explain that a registered Master UDI-DI, UDI-DI or EUDAMED ID can be manually discarded to allow error correction, and that discarded identifiers are not visible to the public.
For certificate rules, Swissmedic states that certificate information and certificate links for regulation devices are not considered by swissdamed, as certificates are referred to EUDAMED through the manufacturer SRN and/or the Basic UDI-DI. For MDD, AIMDD or IVDD devices, manufacturers must specify the directive certificate covering the device, with some exceptions.
Data Exchange Rules
The document includes data exchange business rules for device uploads.
A device upload object should include Basic UDI-DI or EUDAMED DI information, device certificate information where applicable, at least one UDI-DI or EUDAMED ID, optional product original manufacturer information and optional container package information, which is not applicable for legacy devices.
The rules also identify non-updatable and conditionally updatable fields for UDI-DI and Basic UDI-DI records.
Language and SRN Requirements
Swissmedic states that several language-specific properties can be submitted for devices, legacy devices and system or procedure packs, but only one entry per language is accepted for certain fields.
The languages considered for these fields are German, French, Italian or English; other languages are ignored.
The document also defines the SRN format as CC-TT-NNN, where CC is the country code, TT is the actor role code and NNN is a nine-digit numerical value. For companies not registered in EUDAMED and therefore without a legal manufacturer SRN, “NA” can be entered.
Change History
The change history states that version 5.0 includes adaptations to UDI-1107 and UDI-1111, the addition of UDI-1195, and the deletion of UDI-1065.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers registering devices in swissdamed, version 5.0 is relevant because it defines detailed validation and data-entry requirements for UDI-related information.
Manufacturers and regulatory teams should pay particular attention to:
Basic UDI-DI and UDI-DI registration requirements;
mandatory UDI-PI and base quantity fields;
uniqueness of device identifier codes;
registration of legacy devices;
EUDAMED DI and EUDAMED ID formats;
market status management and 30-day draft deletion;
EMDN leaf-code requirements;
applicable legislation and risk class alignment;
Master UDI-DI requirements;
certificate information rules;
language-specific data requirements;
SRN format and mandate consistency.
For companies placing devices on the Swiss market, the key message is that correct and complete swissdamed data remains essential for device registration, lifecycle management and regulatory traceability.
