swissdamed Compliance Guide for Device Manufacturers

Understanding swissdamed and Swiss Device Registration

Overview

Following Switzerland’s departure from the European Union’s medical device regulatory framework, Swissmedic established swissdamed (Swiss Database on Medical Devices) as the national database for managing the registration of economic operators, medical devices, and in vitro diagnostic medical devices supplied in Switzerland. The database supports Switzerland’s medical device regulatory framework under the Medical Devices Ordinance (MedDO) and the In Vitro Diagnostic Medical Devices Ordinance (IvDO), while maintaining a data model closely aligned with EUDAMED to reduce the regulatory burden for manufacturers operating across both jurisdictions.

swissdamed is more than a device registration database. It provides the foundation for identifying economic operators, registering UDI device information, supporting market surveillance activities, and improving the traceability of medical devices placed on the Swiss market. Manufacturers, authorized representatives, importers, and other economic operators each have defined responsibilities within the system that contribute to maintaining accurate and up-to-date regulatory information.

The swissdamed Platform

swissdamed consists of two primary modules supported by public search functionality:

Module	Purpose
Actors Module	Registration and management of economic operators, user accounts, mandates, and permissions.
UDI Devices Module	Registration and lifecycle management of medical devices, IVDs, systems, and procedure packs.

Relationship Between swissdamed and EUDAMED

Although swissdamed has been designed to closely align with the EUDAMED data model, the two systems operate independently.

This alignment enables manufacturers that have already prepared EUDAMED-compliant device data to reuse much of the same information when registering devices in Switzerland. However, there is no technical synchronization between the two databases. Device information submitted to EUDAMED is not automatically transferred to swissdamed, and manufacturers or their authorized representatives must actively register device information separately within the Swiss system.

This means organizations supplying devices in both the European Union and Switzerland should establish processes to maintain consistency between both databases while recognizing that each requires its own submission and ongoing maintenance activities.

Mandatory Device Registration

Registration of economic operators has been mandatory in Switzerland since 26 November 2021 and has been managed through swissdamed since August 2024. Device registration within the UDI Devices Module became mandatory on 1 July 2026 for medical devices, IVDs, systems, and procedure packs placed on the Swiss market. A transitional period allows most applicable devices to be registered until 31 December 2026.

Certain devices are subject to immediate registration from 1 July 2026, including devices associated with:

• Serious incidents
• Field Safety Corrective Actions (FSCAs)
• Trend reporting requirements

These devices must be registered without relying on the general transition period.

Device Registration Scope

The registration requirement applies to:

• Medical devices regulated under the Medical Devices Ordinance (MedDO)
• In vitro diagnostic medical devices regulated under the IvDO
• Systems and procedure packs
• Legacy devices that continue to be placed on the Swiss market after 1 July 2026
• Groups of products without an intended medical purpose that fall within the applicable regulations

Devices already placed on the market before 1 July 2026 must also be registered if additional sales units continue to be supplied after the mandatory registration date.

Registration Methods

Swissmedic provides several methods for registering device information within the UDI Devices Module, allowing organizations to select the most appropriate approach based on product portfolio size, technical capabilities, and operational maturity.

Available registration methods include:

• Online Editor for manual registration through the user interface
• XML Upload using EUDAMED-compatible GET DEVICE or POST DEVICE XML files
• Machine-to-Machine (M2M) integration through a REST API using JSON messages

Organizations already using EUDAMED XML templates may find XML upload particularly efficient because existing EUDAMED XML files can often be reused with minimal modification. Conversely, organizations with smaller device portfolios may prefer the Online Editor, while larger manufacturers typically benefit from automated M2M integration.

Benefits of swissdamed

By establishing a centralized national database for medical devices, swissdamed enables Switzerland to:

• Improve traceability of medical devices supplied within Switzerland
• Strengthen post-market surveillance and vigilance activities
• Support more efficient regulatory oversight by Swissmedic
• Improve transparency for healthcare providers and the public
• Reduce duplicate regulatory effort through alignment with the EUDAMED data model
• Support standardized electronic registration and lifecycle management of medical devices

Device Scope and Swiss UDI Fundamentals

Overview

Before preparing device registrations, manufacturers and authorized representatives should determine whether their devices are subject to registration in swissdamed, identify the applicable UDI requirements, and understand how Swiss device registration aligns with—while remaining separate from—EUDAMED. Although Switzerland has adopted many of the UDI concepts established under the European Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), swissdamed introduces its own registration requirements, timelines, and responsibilities. Understanding these requirements early helps organizations prepare accurate device data, plan registration activities, and avoid unnecessary compliance delays.

Devices Subject to Registration

The registration obligation applies to medical devices placed on the Swiss market under the current Swiss regulatory framework, including:

• Medical devices regulated under the Medical Devices Ordinance (MedDO)
• In vitro diagnostic medical devices regulated under the IvDO
• Systems and procedure packs
• Groups of products without an intended medical purpose that fall within the scope of the MedDO
• Legacy devices that continue to be placed on the Swiss market after the mandatory registration requirements take effect

Manufacturers should assess each device individually, as registration obligations may vary depending on device type, regulatory status, and whether additional units continue to be supplied in Switzerland after the mandatory registration date.

Core UDI Elements in swissdamed

swissdamed uses the same fundamental UDI concepts adopted by the European Union, allowing organizations to leverage much of the device information already prepared for EUDAMED.

Key identifiers include:

• Basic UDI-DI – The primary identifier representing a family of devices with the same intended purpose, risk class, and essential design characteristics
• UDI-DI – The fixed identifier assigned to a specific device model or version
• Package UDI-DI – Identifiers assigned to higher packaging levels
• Secondary UDI-DI – Additional identifiers from another recognized issuing entity, where applicable
• Master UDI-DI – A specialized identifier required for certain highly individualized ophthalmic products, including specified contact lenses, spectacle lenses, spectacle frames, and ready-to-wear reading spectacles

Each UDI-DI can only be associated with one Basic UDI-DI, and each registered Basic UDI-DI must be linked to at least one UDI-DI.

Legacy Devices

swissdamed supports the registration of legacy devices that continue to be supplied in Switzerland under the applicable transitional provisions. Where legacy devices do not have a Basic UDI-DI or UDI-DI, swissdamed allows the use of equivalent EUDAMED DI and EUDAMED ID identifiers to support registration. This helps maintain traceability for devices originally placed on the market under previous regulatory frameworks.

Recognized UDI Issuing Agencies

Manufacturers must obtain UDI identifiers from recognized issuing agencies that comply with Swiss regulatory requirements.

Recognized issuing agencies include:

• GS1
• HIBCC
• ICCBBA (where applicable)
• IFA

For devices requiring a Master UDI-DI, only GS1, HIBCC, and IFA currently support Master UDI-DI allocation.

Device Relationships and Packaging Hierarchies

Manufacturers should ensure that packaging hierarchies accurately reflect how devices are supplied on the Swiss market.

Each applicable packaging level should be associated with its corresponding Package UDI-DI, while maintaining the relationship between:

• Basic UDI-DI
• Device UDI-DI
• Package UDI-DIs
• Secondary identifiers where applicable

Accurate packaging relationships improve traceability and support efficient device identification throughout the supply chain and post-market lifecycle.

Special Device Types

Certain device categories require additional consideration during swissdamed registration.

Examples include:

• Contact lenses requiring a Master UDI-DI
• Spectacle lenses
• Spectacle frames
• Ready-to-wear reading spectacles
• Systems and procedure packs
• Legacy devices registered using replacement identifiers

Manufacturers should review Swissmedic guidance for these product categories to determine any additional registration requirements or implementation timelines.

Economic Operator Responsibilities

Overview

Successful swissdamed compliance depends on clearly defined responsibilities between the various economic operators involved in placing medical devices on the Swiss market. Depending on where a manufacturer is established and how devices are supplied, responsibilities may be shared between manufacturers, Swiss Authorized Representatives (CH-REPs), importers, and other authorized parties.

While many registration activities may be delegated operationally, each economic operator remains responsible for meeting its regulatory obligations under the Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO). Establishing clear governance, documented responsibilities, and effective communication between economic operators is essential for maintaining accurate device registrations throughout the product lifecycle.

Manufacturer Responsibilities

Manufacturers remain primarily responsible for the medical devices they place on the Swiss market.

Key responsibilities include:

• Assigning UDI identifiers through a recognized issuing agency
• Preparing complete and accurate UDI device information
• Ensuring compliance with applicable Swiss regulatory requirements
• Maintaining current device information throughout the product lifecycle
• Determining when product changes require a new UDI-DI
• Providing updated registration information following reportable changes
• Coordinating registration activities with the Swiss Authorized Representative where required

Manufacturers established outside Switzerland must also appoint a Swiss Authorized Representative (CH-REP) where required before placing applicable devices on the Swiss market.

Swiss Authorized Representative (CH-REP) Responsibilities

Manufacturers established outside Switzerland are generally required to designate a Swiss Authorized Representative (CH-REP) before supplying devices in Switzerland.

The CH-REP acts on behalf of the foreign manufacturer and serves as the primary regulatory contact with Swissmedic.

Responsibilities include:

• Registering within the swissdamed Actors Module
• Obtaining and maintaining a Swissmedic Registration Number (CHRN)
• Verifying that the manufacturer has fulfilled applicable regulatory obligations
• Supporting swissdamed device registrations where authorized
• Cooperating with Swissmedic during inspections and regulatory enquiries
• Maintaining regulatory documentation required under Swiss legislation
• Communicating significant regulatory changes with the manufacturer

Although the CH-REP performs regulatory activities on behalf of the manufacturer, responsibility for the device itself remains with the legal manufacturer.

Importer Responsibilities

Importers play an important role within the Swiss regulatory framework by ensuring that only compliant devices are placed on the Swiss market.

Their responsibilities include:

• Verifying that the manufacturer and CH-REP have fulfilled applicable regulatory obligations
• Confirming that required labeling and documentation accompany the device
• Ensuring that devices are correctly identified before supply
• Maintaining importer information where required
• Cooperating with Swissmedic during market surveillance activities

Within swissdamed, importers may also be linked to registered devices, providing greater transparency regarding the supply chain than is currently available within EUDAMED.

Registration of Economic Operators

Before devices can be registered, applicable economic operators must first be registered within the swissdamed Actors Module.

Following successful registration, Swissmedic assigns each registered economic operator a Swissmedic Registration Number (CHRN). The CHRN uniquely identifies the organization within swissdamed and is used across Swiss regulatory processes involving medical devices. Manufacturers, CH-REPs, importers, and other economic operators should ensure that their registration details remain current throughout the organization’s lifecycle.

Delegating Registration Activities

swissdamed allows organizations to authorize individuals or third parties to perform registration activities on their behalf through defined user roles and mandates.

Examples include:

• Internal Regulatory Affairs teams
• Swiss Authorized Representatives
• Regulatory consultants
• Service providers
• Software vendors supporting automated submissions

Operational responsibilities may therefore be delegated, but the legal responsibilities assigned to each economic operator under Swiss legislation remain unchanged.

Organizations should establish documented agreements defining:

• Roles and responsibilities
• Data ownership
• Approval workflows
• Change management
• Ongoing maintenance responsibilities

Coordinating Multiple Economic Operators

Many manufacturers operate through complex distribution models involving multiple importers, distributors, and service providers.

To maintain accurate swissdamed registrations, organizations should establish processes that ensure:

• Device information remains consistent across all regulatory systems
• Registration updates are communicated promptly between economic operators
• Changes affecting device registrations are evaluated consistently
• Responsibilities for lifecycle maintenance are clearly assigned
• Regulatory documentation remains synchronized throughout the supply chain

Well-defined governance helps reduce duplicate effort while maintaining trusted regulatory data across all participating organizations.

Preparing Device Data for swissdamed

Overview

Accurate swissdamed registrations depend on complete, well-structured, and validated device data. Although swissdamed closely aligns with the EUDAMED data model, manufacturers and authorized representatives should not assume that EUDAMED data can be transferred without review or swissdamed specific data validation. Swissmedic applies its own data dictionary, business rules, registration relationships, and technical submission requirements.

Organizations should therefore establish a controlled process for collecting, validating, approving, and transforming device information before it is submitted to swissdamed.

Understanding the swissdamed Data Dictionary

Swissmedic publishes a dedicated UDI Data Dictionary and a separate set of UDI Devices Business Rules for both the production and playground environments. These documents define the data elements, permitted values, formats, validation rules, and relationships that apply to swissdamed registrations.

Organizations should use the current versions of these documents to configure:

• Device data models
• Mandatory and conditional attributes
• Code lists and permitted values
• Validation rules
• XML transformations
• M2M integrations
• Data quality controls
• Change management processes

Because Swissmedic may update its technical documents, manufacturers and authorized representatives should monitor revisions and assess their impact on existing records and submission processes.

Core Registration Data

The information required for swissdamed registration varies according to the device type, regulatory framework, and registration pathway. Core data generally includes:

• Manufacturer and authorized representative information
• Applicable mandate
• Basic UDI-DI or equivalent legacy device identifier
• UDI-DI
• Package UDI-DIs
• Secondary UDI-DIs, where applicable
• Device name, model, or version
• Risk classification
• Applicable legislation
• Nomenclature information
• Device characteristics
• Sterility and reuse information
• Clinical size information, where applicable
• Market status
• Certificate and Notified Body information where required
• Relationships to systems, procedure packs, or other device records

Manufacturers should confirm which attributes are mandatory, optional, or conditionally required by reviewing the current Swissmedic UDI Data Dictionary rather than relying only on data maintained for EUDAMED.

Identifying Authoritative Data Sources

Device data required for swissdamed is often distributed across multiple enterprise systems.

Data Category	Typical Source
Basic UDI-DI and UDI-DI	PLM, PIM, RIM
Device name, model, and version	PLM, PIM, ERP, RIM
Risk classification	PLM, PIM, RIM
Device characteristics	PLM, PIM, technical documentation
Sterility and reuse information	QMS, PLM, manufacturing systems
Clinical sizes	PLM, RIM
Packaging hierarchy	ERP, packaging, or supply chain systems
Market status	Regulatory or commercial systems

An authoritative source should be defined for each data element. This helps prevent conflicting values between product, quality, regulatory, and commercial systems and reduces the risk of inconsistent records across swissdamed, EUDAMED, and other UDI databases.

Preparing Manufacturer and Mandate Data

For foreign manufacturers, device registrations must be associated with the appropriate mandate between the manufacturer and its Swiss Authorized Representative.

Mandates previously reported outside swissdamed were not automatically imported into the database. Existing and new mandates must therefore be entered and maintained within the Actors Module before they can be used for device registration.

Before preparing device submissions, organizations should verify that:

• The manufacturer is correctly represented in swissdamed
• The CH-REP is registered and active
• The appropriate mandate has been created
• The mandate applies to the relevant device portfolio
• Users have the required mandate-level permissions
• The UDI Editor role has been granted where necessary

Incorrect or missing mandate information can prevent a foreign manufacturer or authorized party from registering devices under the correct regulatory relationship.

Reusing EUDAMED Data

Manufacturers that have already registered devices in EUDAMED may reuse much of their existing data, but Swissmedic does not automatically migrate or synchronize EUDAMED records into swissdamed. The relevant economic operator remains responsible for submitting the information separately.

swissdamed supports XML files based on the EUDAMED Device GET and Device POST services. However, several Swiss-specific technical rules apply:

• Manual XML upload requires a one-to-one relationship between each Basic UDI-DI and UDI-DI
• A single XML file may contain up to 300 Basic UDI-DI and UDI-DI pairs
• XML files must conform to the applicable EUDAMED XSD
• The EUDAMED Basic UDI-DI upload service is not supported as a separate swissdamed upload service
• Certain EUDAMED data elements are not stored in swissdamed

Organizations should therefore validate and, where necessary, transform EUDAMED XML before uploading it into swissdamed.

Data Not Transferred Directly from EUDAMED XML

Although swissdamed accepts EUDAMED-compatible XML files, not every EUDAMED element is stored. Swissmedic identifies several exclusions, including certain certificate links, clinical investigation links, authorized representative comments, EUDAMED market information, and unsupported language values.

This means that successful technical acceptance of an XML file does not remove the need to review whether the resulting swissdamed record is complete and appropriate for Switzerland.

Organizations should reconcile:

• The original EUDAMED record
• The submitted XML
• The accepted swissdamed record
• Any Swiss-specific fields or relationships
• Market status and mandate information

Preparing Packaging Relationships

Packaging hierarchies should accurately represent how devices are placed on the Swiss market.

Before submission, manufacturers should confirm:

• The correct UDI-DI for the individual device
• All applicable Package UDI-DIs
• The quantity of lower packaging levels contained within each package
• Parent-child packaging relationships
• Consistency with approved labeling and commercial configurations
• Whether package information differs between Switzerland and other markets

Incomplete or inaccurate packaging relationships can affect traceability and lead to validation errors or incorrect public information.

Preparing Legacy Device Data

Legacy devices may require different identifiers from devices certified under the current MedDO or IvDO framework.

Organizations should identify:

• Whether the device qualifies as a legacy device
• Whether it has an existing Basic UDI-DI and UDI-DI
• Whether an EUDAMED DI and EUDAMED ID must be used instead
• The applicable regulatory status and certificate information
• Whether the device continues to be placed on the Swiss market after the mandatory registration date

Legacy device data should be managed separately during data preparation because identifier requirements and permitted attributes may differ from those for current regulation devices.

Preparing Importer Information

Importers do not register devices themselves. Once a device has been registered, each importer placing that device on the Swiss market must link its actor record to the device using the UDI-DI. This linking can occur only after the device has been registered by the authorized representative, foreign manufacturer under a mandate, or other permitted registering party.

Manufacturers and CH-REPs should therefore maintain an accurate list of:

• Swiss importers
• Devices supplied by each importer
• Relevant UDI-DIs
• Importer onboarding status
• Outstanding importer links
• Changes to distribution relationships

Importer coordination should be included in the data-readiness plan even though importer details are not submitted as part of the original device registration.

Conducting a UDI Data Readiness Assessment

Before beginning registration, organizations should assess their portfolio for:

• Missing mandatory attributes
• Invalid or unsupported code values
• Incorrect UDI formats
• Missing Basic UDI-DI and UDI-DI relationships
• Incomplete packaging hierarchies
• Missing or incorrect mandates
• Devices assigned to the wrong CH-REP
• Missing certificate or Notified Body information
• Unsupported language values
• Incomplete importer mapping
• Incorrect market status
• Duplicate device records
• Differences between EUDAMED and Swiss data
• Legacy devices requiring alternative identifiers

The assessment should prioritize devices that must be registered immediately, including devices associated with reportable serious incidents, field safety corrective actions, or trend reports.

Establishing a Controlled Submission Dataset

Before registration, the proposed swissdamed dataset should be reconciled against:

• Approved labeling and packaging
• Technical documentation
• Declaration of Conformity
• Certificate information
• Issuing agency records
• EUDAMED records where reused
• The swissdamed Actors Module
• CH-REP mandates
• Swiss importer information
• Current Swissmedic data dictionary and business rules

Only reviewed and approved device data should proceed to XML generation, M2M transmission, or manual entry.

swissdamed Access and Registration

Overview

Before medical devices can be registered in swissdamed, the appropriate economic operators must be registered in the Actors Module, assigned the required user permissions, and granted access to the UDI Devices Module. Swissmedic supports multiple registration methods to accommodate organizations with varying portfolio sizes and technical capabilities, ranging from manual data entry to fully automated system-to-system integration.

Selecting the appropriate registration method depends on factors such as the number of devices being registered, the frequency of lifecycle updates, the organization’s IT capabilities, and the level of automation required.

Registering Economic Operators

Access to the UDI Devices Module begins with registration in the swissdamed Actors Module.

Manufacturers, Swiss Authorized Representatives (CH-REPs), importers, and other applicable economic operators must first complete actor registration before they can perform activities within swissdamed.

Following successful registration, Swissmedic assigns each organization a unique Swissmedic Registration Number (CHRN), which serves as the organization’s regulatory identifier within the Swiss medical device framework.

Organizations should ensure that their actor information remains accurate and current, including:

• Organization details
• Contact information
• Regulatory role
• Mandates
• Authorized users
• CHRN information

User Roles and Permissions

swissdamed uses role-based access controls to ensure that only authorized users can perform specific regulatory activities.

Typical user permissions include:

• Administrator – Manages the organization’s users, permissions, and mandates.
• UDI Editor – Creates, edits, validates, and maintains device registrations.
• Authorized Users – Perform activities permitted by their assigned role.

User permissions should align with each individual’s regulatory responsibilities while supporting appropriate segregation of duties and internal governance.

Organizations should periodically review user access to ensure permissions remain appropriate as responsibilities change.

Managing Mandates

For manufacturers established outside Switzerland, mandates play a critical role in swissdamed.

The Actors Module allows organizations to establish and manage mandates between foreign manufacturers and their Swiss Authorized Representatives.

Before device registration begins, organizations should verify that:

• The manufacturer is registered
• The CH-REP is registered
• The mandate has been created
• The mandate has been accepted
• Appropriate user permissions have been assigned

Device registrations cannot be completed correctly if the required mandate relationship has not been established.

Registration Method 1: Online Editor

The Online Editor provides a web-based interface for manually creating and maintaining device registrations in swissdamed.

It is most appropriate for:

• Small product portfolios
• Low submission volumes
• Individual corrections
• Occasional lifecycle updates
• Organizations without automated integrations

The Online Editor performs interactive validation during data entry, allowing users to identify issues before final submission.

Registration Method 2: XML Upload

Organizations with larger portfolios may upload XML files directly into swissdamed.

Swissmedic supports XML files based on the EUDAMED Device GET and Device POST XML formats, allowing manufacturers to reuse much of their existing EUDAMED device data.

Before uploading XML files, organizations should verify that:

• Files conform to the supported XML schema
• Required Swiss-specific data has been included
• Unsupported EUDAMED elements have been removed or adjusted where necessary
• Basic UDI-DI and UDI-DI relationships satisfy swissdamed business rules

XML upload provides an efficient option for organizations migrating small to medium device portfolios while avoiding repetitive manual data entry.

Registration Method 3: Machine-to-Machine (M2M)

Organizations with high submission volumes may automate registrations through the swissdamed REST API.

Unlike EUDAMED’s AS4 eDelivery architecture, swissdamed supports modern REST-based Machine-to-Machine communication using JSON messages.

REST API integration is well suited for organizations that:

• Register large product portfolios
• Frequently update device information
• Integrate Regulatory Information Management (RIM), PIM, PLM, or MDM systems
• Require automated lifecycle synchronization

Before Production access is granted, organizations should complete Swissmedic’s technical onboarding process and validate their integration using the available testing environment.

Choosing the Appropriate Registration Method

The most suitable registration method depends on an organization’s operational requirements.

Registration Method	Best Suited For	Primary Considerations
Online Editor	Small portfolios and occasional updates	Manual entry with interactive validation
XML Upload	Small to medium portfolios	Efficient reuse of EUDAMED XML data
REST API (M2M)	Large portfolios and ongoing synchronization	Fully automated integration using JSON

Data Validation During Registration

Regardless of the submission method, swissdamed validates incoming registrations against predefined technical and business rules.

Validation activities include verification of:

• Mandatory attributes
• Identifier formats
• Data relationships
• Packaging hierarchies
• Device classifications
• Permitted values
• Mandate relationships
• User permissions

Organizations should review validation results promptly and resolve any identified issues for timely compliance.

Best Practices

Successful onboarding to swissdamed begins before the first device registration.

Organizations should:

• Complete Actor registration early
• Confirm CHRN assignments
• Establish and verify mandates
• Assign appropriate user permissions
• Select the registration method that aligns with long-term operational needs
• Validate XML or REST API integrations before Production use
• Test representative device registrations before submitting large portfolios

Monitor validation responses and resolve errors promptly.

Best Practice swissdamed Submission Process

Overview

For successful swissdamed compliance, manufacturers and other economic operators should establish a structured, repeatable process that ensures device information is prepared, validated, submitted, and maintained throughout the product lifecycle.

Although swissdamed supports multiple registration methods—including the Online Editor, XML upload, and REST API integration—the underlying business process remains largely the same. A standardized workflow improves data quality, reduces registration errors, and helps organizations maintain accurate device information as products and regulatory requirements evolve.

Step 1: Confirm Registration Scope

Before preparing a registration, organizations should determine whether the device is subject to swissdamed registration.

This assessment should confirm:

• The applicable Swiss regulatory framework (MedDO or IvDO)
• Device classification
• Whether the device is a current or legacy device
• Applicable registration timelines
• Whether any device-specific registration requirements apply
• Whether the manufacturer and CH-REP have completed Actor registration

Completing this assessment early helps prioritize registration activities and reduces delays during implementation.

Step 2: Prepare Device Data

Device information should be collected from approved source systems and reconciled against current regulatory documentation for swissdamed.

Organizations should verify:

• Basic UDI-DI and UDI-DI assignments
• Package UDI-DIs
• Device name, model, and version
• Device characteristics
• Classification
• Certificate information where applicable
• Packaging relationships
• Market status
• Manufacturer and CH-REP information
• Mandate information

Only validated and approved information should be included in the registration dataset for swissdamed.

Step 3: Validate Registration Readiness

Before submission, organizations should verify that the registration dataset satisfies the current swissdamed data dictionary and business rules.

Validation activities should include:

• Mandatory and conditional attributes
• Identifier formats
• Packaging hierarchies
• Device relationships
• Supported code values
• Mandate relationships
• User permissions
• XML or JSON structure where applicable

Validating device data before submission significantly reduces processing errors and rework.

Step 4: Review and Approve Registration Data

Device information should undergo an internal review before submission.

Organizations should establish documented approval workflows to verify that submitted information accurately reflects approved regulatory documentation, labeling, certificates, and device specifications.

Formal review processes strengthen governance while reducing the likelihood of inaccurate registrations.

Step 5: Submit Device Information

Once approved, organizations may register devices using the most appropriate submission method:

• Online Editor
• XML Upload
• REST API Machine-to-Machine integration

Regardless of the submission method, organizations should ensure that the submitted information corresponds to the approved registration dataset.

Step 6: Review Submission Results

Following submission, swissdamed validates incoming registrations against predefined technical and business rules.

Organizations should review submission responses promptly to confirm that:

• The registration was accepted
• Mandatory attributes have been successfully processed
• No validation errors remain unresolved
• Device relationships have been correctly established
• The device record has been successfully published

Timely review enables organizations to resolve issues before they affect downstream regulatory activities.

Step 7: Correct Validation Errors

If validation errors occur, organizations should investigate the underlying cause before resubmitting corrected information.

Rather than correcting individual records in isolation, organizations should determine whether similar issues affect other devices or originate from upstream enterprise systems.

Addressing root causes improves overall data quality while reducing repetitive registration errors.

Step 8: Maintain Registered Device Information

Registration is an ongoing responsibility rather than a one-time activity.

Manufacturers and authorized representatives should establish controlled processes for maintaining swissdamed records whenever reportable changes occur, including:

• Device modifications
• New UDI-DIs
• Packaging updates
• Certificate changes
• Manufacturer information
• CH-REP information
• Mandate changes
• Market status changes
• Legacy device updates

Maintaining current device information supports regulatory compliance while improving traceability throughout the device lifecycle.

Step 9: Monitoring Registration Activities

Organizations should routinely monitor:

• Registration status
• Validation outcomes
• Rejected registrations
• Outstanding corrections
• Devices awaiting registration
• Devices requiring lifecycle updates

Monitoring operational performance enables organizations to identify trends, improve data quality, and maintain regulatory compliance over time.

Step 10: Best Practices

Successful swissdamed registrations are supported by disciplined operational processes. Organizations should:

• Confirm registration scope before preparing submissions
• Establish authoritative data sources for all registration attributes
• Validate device data before submission
• Require documented regulatory approval before submitting records
• Monitor submission responses and resolve errors promptly
• Investigate the root cause of recurring data validation issues
• Maintain complete audit trails and registration histories
• Keep device records current throughout the product lifecycle
• Periodically review data quality and registration performance metrics

System Quality, Validation and Security

Overview

Successful swissdamed compliance depends not only on preparing accurate device data but also on maintaining systems that support secure, reliable, and controlled regulatory processes. Organizations should establish appropriate quality, validation, and security controls for the systems used to create, review, approve, submit, and maintain device registrations throughout the product lifecycle.

Whether device information is entered manually through the Online Editor or submitted using XML uploads or Machine-to-Machine (M2M) integration, organizations remain responsible for ensuring the integrity, accuracy, and security of regulatory information submitted to swissdamed.

Maintaining Data Integrity

Trusted device registrations begin with trusted product data.

Organizations should establish controls that ensure device information remains:

• Attributable to an authorized source
• Accurate and complete
• Consistent across enterprise systems and regulatory databases
• Protected from unauthorized modification
• Available throughout the required retention period
• Traceable through all updates and corrections

Computer System Validation

Organizations should apply a risk-based Computer System Validation (CSV) approach to systems supporting swissdamed registration activities.

Systems that create, transform, approve, or transmit regulatory data should be validated according to their intended use and potential impact on regulatory compliance.

Validation activities may include:

• User Requirements Specifications (URS)
• Functional and configuration specifications
• Risk assessments
• Installation, operational, and performance qualification where appropriate
• Interface and integration testing
• XML and REST API message validation
• User Acceptance Testing (UAT)
• Traceability between requirements and test evidence
• Controlled deployment and change management

Many manufacturers leverage GAMP 5 principles to implement scalable validation approaches that align validation effort with system risk while supporting efficient lifecycle management for registered devices.

Electronic Records and Electronic Signatures

Although Swiss medical device legislation does not prescribe electronic record requirements equivalent to 21 CFR Part 11, many manufacturers operate within global quality systems that support multiple regulatory jurisdictions.

Organizations should therefore consider implementing controls consistent with internationally recognized good practices, including:

• Unique user identification
• Role-based access control
• Secure authentication
• Audit trails
• Electronic signatures where used
• Record retention
• Protection against unauthorized modification
• Controlled approval workflows

Organizations supporting both Swiss and international regulatory activities often align these controls with 21 CFR Part 11 and EU Annex 11 to maintain a consistent enterprise compliance framework.

Security Controls

Systems supporting swissdamed registrations should implement appropriate technical and organizational security measures to protect regulated device information.

Recommended controls include:

• Role-based access control
• Secure credential management
• Network security monitoring
• Vulnerability and patch management
• Backup and disaster recovery
• Security incident response procedures
• Periodic user access reviews
• Third-party security assessments

Organizations should also establish processes to manage privileged accounts, monitor unauthorized access attempts, and regularly review security configurations supporting regulatory systems.

Integration and Interface Controls

Organizations using XML upload or REST API integration should establish additional controls to ensure reliable data exchange between enterprise systems and swissdamed.

These controls should include:

• Interface validation
• Message integrity verification
• Automated error handling
• Retry mechanisms for failed transmissions
• Logging of submitted messages
• Monitoring of integration performance
• Reconciliation of submitted and accepted records
• Controlled interface changes

Robust interface controls help reduce manual intervention while improving the reliability and consistency of automated registration processes.

Managing Third-Party Service Providers

Many organizations rely on external software vendors, regulatory consultants, system integrators, or managed service providers to support swissdamed registration activities.

When third parties are involved, organizations should establish documented agreements covering:

• Regulatory responsibilities
• Data ownership
• Information security
• System validation responsibilities
• Business continuity
• Incident management
• Change management
• Service level expectations

Although operational activities may be delegated, the applicable economic operator remains responsible for ensuring compliance with Swiss medical device regulations.

Change Management

Changes to systems supporting swissdamed registrations should be evaluated using formal change control procedures.

Typical changes include:

• Software upgrades
• API version changes
• XML schema updates
• Data model revisions
• Swissmedic technical specification updates
• Security configuration changes
• Infrastructure modifications
• Integration enhancements

Each change should be assessed for its potential impact on regulatory submissions, validated where appropriate, and approved before implementation.

Periodic Review

Validated systems should not remain static following implementation.

Organizations should periodically review:

• System performance
• User access permissions
• Integration reliability
• Security controls
• Outstanding software defects
• Backup and recovery procedures
• Compliance with current Swissmedic technical documentation

Periodic reviews help ensure systems remain fit for their intended purpose as regulatory requirements, business processes, and technology evolve.

Best Practices

Organizations should:

• Apply a risk-based validation approach for systems supporting swissdamed
• Maintain complete audit trails for regulatory activities
• Implement strong access controls and security measures
• Validate XML and REST API integrations before production use
• Establish formal change management procedures
• Periodically review system performance and validation status
• Monitor integration performance and investigate recurring issues
• Maintain documented procedures supporting secure and reliable regulatory operations

Best Practices for Successful swissdamed Compliance

Overview

Achieving compliance with swissdamed requires more than completing initial device registrations. Manufacturers, Swiss Authorized Representatives (CH-REPs), and other economic operators should establish standardized processes that support accurate device information throughout the product lifecycle.

Successful organizations treat swissdamed as an ongoing regulatory capability rather than a one-time implementation project. By combining trusted product data, well-defined governance, validated systems, and continuous monitoring, organizations can improve registration quality, reduce compliance risk, and adapt efficiently as Swiss regulatory requirements continue to evolve.

Integrate swissdamed into Regulatory Operations

swissdamed activities should be incorporated into everyday regulatory operations rather than managed as standalone projects.

Organizations should establish documented procedures covering:

• Device registration
• Lifecycle updates
• UDI management
• Packaging changes
• Certificate updates
• Change management
• Regulatory approvals
• Record maintenance

Embedding swissdamed into routine business processes helps ensure device information remains accurate throughout the product lifecycle while reducing the risk of missed regulatory obligations.

Establish Clear Governance Across Economic Operators

Successful swissdamed compliance requires effective collaboration between manufacturers, Swiss Authorized Representatives (CH-REPs), importers, and other participating organizations.

Responsibilities should be clearly defined for:

• Device data ownership
• Regulatory approvals
• Registration activities
• Change management
• Mandate management
• Importer coordination
• Ongoing record maintenance

Formal governance processes improve accountability while reducing duplicate effort and conflicting regulatory information.

Maintain a Single Source of Trusted Device Data

Accurate UDI registrations depend on trusted product data.

Organizations should establish authoritative sources for device information and ensure that product data remains consistent across:

• PLM
• ERP
• RIM
• QMS
• PIM or MDM
• Labeling systems
• EUDAMED
• swissdamed
• Other UDI databases

Maintaining a single source of trusted UDI data helps reduce inconsistencies while improving the quality of regulatory submissions.

Validate Data Before Registration

Correcting errors before registration is significantly more efficient than resolving submission failures.

Organizations should validate:

• Mandatory attributes
• Supported code values
• UDI formats
• Device relationships
• Packaging hierarchies
• Mandates
• Market status
• XML or REST API messages
• Swissmedic business rules

Comprehensive pre-submission data validation improves registration quality while reducing delays caused by rejected submissions.

Leverage Automation Where Appropriate

As product portfolios grow, manual registration processes become increasingly difficult to manage.

Organizations should evaluate opportunities to automate:

• Data extraction
• Data transformation
• Data validation
• XML generation
• REST API submissions
• Registration monitoring

Automation improves consistency, reduces manual effort, and enables Regulatory Affairs teams to focus on higher-value compliance activities.

Maintain Secure and Validated Systems

Systems supporting swissdamed registrations should remain secure, reliable, and appropriately validated throughout their operational lifecycle.

Organizations should:

• Apply risk-based computer system validation
• Protect regulated electronic records
• Maintain comprehensive audit trails
• Enforce role-based access controls
• Implement formal change management
• Periodically review system performance and security controls

Many global manufacturers adopt recognized practices such as GAMP 5, 21 CFR Part 11, and EU Annex 11 to establish consistent quality and compliance controls across international regulatory systems.

Monitor Registration Performance

Organizations should establish performance metrics that support continuous improvement.

Examples include:

• Registration completion rates
• Validation error trends
• Registration processing times
• Outstanding lifecycle updates
• Data quality metrics

Regular review of operational metrics enables organizations to identify opportunities for improvement while strengthening long-term UDI compliance.

Stay Current with Regulatory Changes

Swiss medical device regulations, technical documentation, and swissdamed functionality continue to evolve.

Organizations should regularly monitor updates published by Swissmedic, including:

• Technical documentation
• UDI Data Dictionary revisions
• Business rule updates
• XML schemas
• REST API specifications
• User Guides
• Regulatory guidance documents

Proactively assessing these updates enables organizations to adapt systems and processes before new requirements become effective.

Foster Cross-Functional Collaboration

Successful swissdamed compliance extends beyond Regulatory Affairs.

Organizations should encourage collaboration between:

• Regulatory Affairs
• Quality Assurance
• Product Management
• Supply Chain
• Manufacturing
• Packaging
• IT
• Master Data
• Swiss Authorized Representatives
• Commercial partners where appropriate

Cross-functional collaboration improves data quality, strengthens governance, and helps ensure that regulatory information remains consistent across the organization.