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Swissdamed
UDI Solutions

Navigating Swiss market requirements under the Swiss Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Devices Ordinance (IvDO) requires a clear, reliable submission process. To maintain compliance and protect market access, medical device and IVD manufacturers must submit complete Unique Device Identification (UDI) data directly to the official Swiss database.

At DDi, we take the administrative burden off your teams. Combining deep regulatory intelligence with high-performance automation, our end-to-end services and Swissmedic device registration software handle initial actor setups, bulk UDI filings, and ongoing lifecycle changes – keeping your device portfolio fully compliant with evolving Swiss regulations.

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Understanding the Two-Step Swissdamed
Registration Process

Ensure seamless compliance across the entire regulatory submission lifecycle with our structured two-
step process.

1. Actor Registration

Before submitting product details, manufacturers must complete “Actor” registration in Swissdamed to receive their unique identification credentials. Establishing your actor profile is a mandatory prerequisite for all subsequent device submissions.

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2. A Strategic Data Foundation

Once actor approval is granted, manufacturers must register each medical device and IVD along with its assigned UDI attributes. For businesses managing hundreds or thousands of SKUs, compiling, validating, and submitting individual device attributes can strain internal bandwidth.

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3 Options to ensure Your Swissmedic Compliance

PATHWAY A

You Are Already Registered in EUDAMED

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Automated Data Retrieval: We use your existing EU Single Registration Number (SRN) to pull validated product data directly from EUDAMED.

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Portfolio Refinement: Quickly review your pulled catalog, remove irrelevant lines, and finalize the exact list needed for Switzerland.

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Direct M2M Submission: Our EUDAMED to Swissdamed M2M integration utilizes our proprietary smartGate pathway to automatically transmit compliant XML files to Swissdamed, or deliver ready-to-upload ZIP archives directly to your team.

PATHWAY B

You Are Not Yet Registered in EUDAMED

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Simplified Data Onboarding: Maintain your product details in standard spreadsheet formats.

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Portal Transformation: Upload your spreadsheets into our intuitive portal, where built-in tools automatically validate and convert your data into the required XML formats.

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Flexible Pay-Per-Use Pricing: Scale your compliance costs based on your active submission volume without heavy upfront commitments.

PATHWAY C

You Need Master Data Management & Lifecycle Support

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Master Data Management Included: Functions as your central system-of-truth to maintain product details without needing external tools.

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Cross-Functional Data Updates:Individual, user-friendly screens allow each business function (Product, Regulatory, Packaging, Labeling, UDI, etc.) to directly update their data.

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Validation Checks via Visu UDI: Data is run through Visu UDI to verify compliance.

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Automated Filing via smartRules: Our proprietary smartRules engine tracks daily data updates, identifies items qualifying for country-specific UDI submissions, and automatically publishes the required files.

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Validation Alerts: Receive instant alerts for any validation failures so you can manually correct the data.

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Lifecycle Maintenance: All ongoing data maintenance is performed entirely within Visu UDI – no Excel spreadsheets required.

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Cloud-Based & Validated: Delivered as a fully validated, cloud-based solution on an annual license model.

Strategic Regulatory Consultancy & Ongoing
Support

Beyond software, DDi delivers hands-on expert advisory services.

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Strategic Guidance

Receive tailored advice on Swiss transition periods, legacy device rules, and critical regulatory deadlines.

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Incident & Error Resolution

Dedicated support packages to quickly troubleshoot submission errors, failed submissions, or data mismatch alerts.

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Validated Templates

Gain access to pre-formatted, validated UDI collection templates that ensure your internal master data is instantly Swissdamed-ready.

Ready to streamline your Swissdamed UDI journey?

Contact us to schedule a free introductory meeting or request a demo of our Swissdamed UDI Solutions management software.

Schedule Personalized Demo

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Frequently Asked Questions

Everything you need to know about Swissdamed compliance and Swissmedic device registration.

faq-question

1. What is the two-step Swissdamed registration process?

  • Actor Registration: Register your company to receive mandatory identification credentials.
  • Device Registration: Submit assigned UDI data for each medical device and IVD.
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2. How can EUDAMED users submit data to Swissdamed?

DDi’s Pathway A pulls your EUDAMED data using your SRN and automatically transmits compliant XML files to Swissdamed via smartGate M2M integration.
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3. How do non-EUDAMED companies submit Swissdamed data?

DDi’s Pathway B lets you upload product spreadsheets into a portal that automatically validates and converts data into Swissdamed XML files on a pay-per-use model.
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4. What is DDi’s solution for ongoing UDI lifecycle management?

DDi’s Pathway C ( Visu UDI ) is a cloud-based system that centralizes product data, runs validation checks, and uses smartRules to automate continuous filing updates.
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5. What are DDi’s three Swissdamed compliance pathways?

  • Pathway A: Automated EUDAMED-to-Swissdamed transfer.
  • Pathway B: Spreadsheet-to-XML portal for non-EUDAMED users.
  • Pathway C: Complete Master Data Management and lifecycle automation.
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6. What regulatory services does DDi provide besides software?

DDi offers strategic advisory on Swiss transition rules, error troubleshooting, and pre-validated UDI data collection templates.

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7. How does DDi handle Swissdamed submission errors?

DDi provides dedicated support to rapidly fix validation failures, data mismatches, and submission errors to protect market access.
The First Step

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