The smart solution for compliant UDI data management in swissdamed
Structured preparation of your swissdamed product registration – efficient, traceable and regulatory-compliant.
Your challenge is our solution
With swissdamed, Swissmedic operates the central Swiss database for medical devices, in vitro diagnostics as well as systems and procedure packs. For manufacturers, Swiss Authorised Representatives and other economic operators, this creates a new operational challenge: UDI data must be prepared, checked and submitted completely, structurally and in line with swissdamed requirements.
Our swissdamed Excel template provides the first structured step – developed by UDI experts for companies that want to prepare their product data efficiently, transparently and with a strong compliance focus.
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The swissdamed UDI Excel template at a glance:
Comprehensive tabs for your swissdamed-relevant UDI data:
- Basic UDI-DI tab:
In this tab, you enter the higher-level master data for the unique identification of your product family. This data forms the basis for the structured assignment of the individual UDI-DIs in the swissdamed UDI Devices module.
- Assignment and documentation of the Basic UDI-DI according to the specifications of the responsible issuing entity, e.g. GS1, HIBCC or ICCBBA.
- Assignment of the responsible economic operator, e.g. Swiss manufacturer, Swiss Authorised Representative or manufacturer of systems and procedure packs.
- Recording of relevant actor information, in particular the CHRN or the actor information registered in swissdamed.
- Assignment of the product type and risk class according to the applicable requirements under MedDO/IvDO or the underlying MDR/IVDR structures.
- Definition of whether the product is a medical device, an in vitro diagnostic, a system or a procedure pack.
- Documentation of characteristics such as active device, measuring function, administration function, implantable device, reusable surgical instrument or other special device types.
- Recording of the device model, device name and further descriptive information relating to the product family.
- Specification of special components or characteristics, e.g. animal or human tissues or cells, CMR/endocrine substances or other regulatory-relevant information.
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- UDI-DI tab:
In this tab, all product-specific individual data required for the unique identification and traceability of a specific medical device or IVD is recorded. The UDI-DI serves as the central identifier for product registration in swissdamed.
- Linking to the higher-level Basic UDI-DI for assignment to a product family.
- Recording of the internal material number and material description for unique assignment within your company.
- Assignment of the UDI-DI by a recognised issuing entity and entry of the unique UDI-DI code.
- Definition of the product status, e.g. active, inactive, withdrawn or in preparation.
- Recording of the quantity per sales unit as well as further information on product and packaging logic.
- Documentation of the reference number for identification in technical documentation, labelling or packaging.
- Information on direct marking on the product, where relevant.
- Sterile labelling and indication of whether sterilisation before use is required.
- Indication of whether the product is labelled as single-use or has been reprocessed.
- Production identification: lot or batch number, expiry date, manufacturing date, serial number and software version.
- Additional identifiers such as secondary UDI-DI, Unit of Use DI or other identifiers, where required.
- Further information such as URL for electronic instructions for use or additional product information.
- Certificate information:
- Recording of the related Basic UDI-DI code for clear linkage with the certificate.
- Entry of the certificate number and management of the revision number, e.g. in the event of renewals or changes.
- Selection of the certificate type and indication of the notified body, where relevant for the product.
- Documentation of the expiry date and further certificate data for products for which this information is required for registration.
- Clinical investigation / performance study
- Entry of relevant identifiers for clinical investigations or performance studies, where these must be specified for the product.
- Indication of the country in which the clinical investigation or performance study was carried out.
- Language & medical purpose
- Selection of the language in which product-related information is provided.
- Description of the medical purpose as well as further language-dependent product information.
- Packaging information / packaging hierarchy:
In this tab, information on packaging units and subordinate UDI-DI structures is documented – particularly relevant for multi-level packaging, sets as well as systems and procedure packs.
- Internal material number of the packaging unit for unique identification.
- Issuing entity for the packaging UDI-DI.
- Entry of the UDI-DI code of the packaging, e.g. for outer packaging, sets or multi-level packaging hierarchies.
- Status of the packaging unit.
- Specification of subordinate UDI-DIs within the packaging unit.
- Quantity per package for the correct representation of the packaging hierarchy.
- Storage & handling conditions
- Assignment of storage and handling conditions to the relevant UDI-DI.
- Specification of the type of condition, e.g. temperature, humidity, protection from light or other requirements.
- Language-dependent description to explain specific storage or handling instructions in greater detail.
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- Critical warnings
- Selection and documentation of relevant warning types, e.g. implant, latex, radioactivity or other product-related warnings.
- Size information
- Specification of the size format, e.g. numeric, alphanumeric or symbolic.
- Accuracy or precision of the size information.
- Size unit as well as minimum and maximum values.
- Medical human substances
- Selection of the substance type.
- Entry of the international non-proprietary name, where available.
- Indication of the language for language-specific representation.
- Free-text designation of the substance, e.g. commonly used national name or additional description.
- CMR/endocrine substances
- Selection of the substance type, e.g. CMR category or endocrine disruptor.
- Specification of the CAS code and EC code, where available.
- Language-dependent name or description of the substance.
- Additional product description
- Selection of the language in which the additional description is to be provided.
- Recording of supplementary product information, e.g. on function, composition, specific characteristics of the set or specific product variant.
- Trade name
- Selection of the language for the trade name.
- Entry of the trade name, e.g. product name, model name or market-relevant designation.
- Nomenclature code
- Selection and documentation of the appropriate nomenclature code according to the requirements relevant for swissdamed.
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Intelligent functions for maximum efficiency:
- Colour highlighting of mandatory fields:
- Immediate visual identification of mandatory entries.
- Distinction between absolute mandatory fields and conditionally required fields.
- Context-related display of relevant fields based on previous entries.
- Validated drop-down menus:
- Predefined selection options according to swissdamed-relevant data structures.
- Reduction of input errors through standardised options.
- Consistent terminology for Regulatory Affairs, Quality Management and IT.
- Automatic dependency checks:
- Dynamic adjustment of input fields based on product type, classification and actor role.
- Logical check of data consistency between different tabs.
- Warnings in the event of potential inconsistencies in data entry.
- Bilingual support:
- Parallel descriptions in German and English.
- International usability for global teams, Swiss Authorised Representatives and external partners.
- Consistent terminology for swissdamed, UDI data and regulatory processes.
- Documentation support:
- Integrated explanations for complex fields.
- Notes on regulatory requirements and data dependencies.
- Support in preparing data for review, conversion and submission.
Comprehensive service offering for your swissdamed compliance
- swissdamed UDI Excel template: the professional basis for structured UDI data entry and preparation of product registration in swissdamed.
- Data review and validation: We support you in the expert review of your UDI data so that typical inconsistencies can be identified and corrected before submission.
- XML and upload preparation: The conversion of your structured data into a suitable technical format is provided as a separate service by our experts.
- swissdamed submission service: We accompany the entire data submission process – from preparation and Playground testing through to productive registration, as soon as the respective functions are available and applicable.
Technical specifications of the Excel template
- File format: Microsoft Excel (.xlsx)
- Compatibility: Microsoft Excel 2016 and later
- Size: Optimised for fast loading times, even with extensive data sets
- Security: Password-protected structures to prevent unintended changes
- Updates: Regular updates in line with new swissdamed requirements and technical specifications
- Data validation: Integrated check routines for consistent entries
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Why leading medical technology companies trust our solution
Europe IT Consulting GmbH is not only ISO 9001-certified and an SAP partner – we are your strategic partner for the digital transformation of your regulatory processes. Our focus is on UDI data management, data validation and the technical preparation of regulatory data submissions.
What makes our swissdamed Excel template unique:
- Precise structuring according to the requirements of the swissdamed UDI Devices module
- Intelligent drop-down menus with validated selection options
- Visual highlighting of mandatory fields and dependent fields
- Intuitive navigation through the complex world of UDI data
- Multilingual support for international teams, Swiss Authorised Representatives and external partners
- Optimal preparation for data review, technical conversion and swissdamed submission
- ANALYSE: Identify the need for action for your product registration in swissdamed. “The first step towards structured Swiss UDI compliance”
- ACQUIRE: Secure access to our swissdamed Excel template. “The foundation of your regulatory data strategy for Switzerland”
- IMPLEMENT: Record your product data in a clear and reviewable template structure. “No more unclear UDI data entry”
- BENEFIT: Commission us for validation, technical preparation and swissdamed submission. “Focus on your core business while we support the technical implementation”
Perfectly aligned with your individual requirements
For small and medium-sized product portfolios:
The Excel template is the ideal basis for structured data entry – supplemented by our review, conversion and submission service.
For extensive product lines:
The perfect foundation for scalable upload or M2M processes for larger data volumes – with additional support from our IT and UDI experts.
For SAP users:
Maximise your benefit through seamless integration with our UDI solutions and existing regulatory master data.
For companies with existing EUDAMED data:
Use existing data sets as a starting point – however, swissdamed is an independent Swiss database. There is no automatic synchronisation with EUDAMED. The data must be actively prepared and submitted for swissdamed.
Frequently asked questions to support your decision
Are there additional costs for updates to the Excel template?
Important updates to the template are included in the purchase, provided they relate to regular maintenance of the template structure and value lists. In the case of extensive regulatory or technical changes, separate coordination may be required.
Can I use the Excel template to create XML files for swissdamed myself?
No. The Excel template primarily serves the structured recording and preparation of your UDI data. Technical conversion or preparation for upload is offered by us as a separate service.
How are my data submitted to swissdamed?
After data entry, you can use our submission service. Depending on the project status and availability of technical functions, we support you with manual submission, XML preparation, Playground testing and M2M preparation.
Can I use existing EUDAMED data for swissdamed?
Yes, existing EUDAMED data can often serve as a valuable starting point. Nevertheless, the data must be checked, adapted and actively submitted for swissdamed. There is no automatic synchronisation between EUDAMED and swissdamed.
What prerequisites do I need for swissdamed?
As a rule, the responsible economic operator must be registered in swissdamed. Depending on the role, this may apply, for example, to Swiss manufacturers, Swiss Authorised Representatives or manufacturers of systems and procedure packs. For certain processes, additional user rights, roles and technical access credentials are required.
How are my entered data secured?
The Excel template stores data locally in your file. We also recommend regular backups in accordance with your internal IT and quality management requirements.
Can I use the template for several products or product lines?
Yes. The template is designed to manage several Basic UDI-DIs and numerous associated UDI-DIs in a structured format.
Do I need special Excel skills?
No. Basic Excel skills are sufficient. The structure, drop-down menus, colour indicators and explanations support users during data entry.
Will the template be updated in the event of regulatory changes?
Yes. We monitor the relevant swissdamed developments and adapt the template when data structures, value lists or technical requirements change.
Act now – secure your advantage for Swiss product registration!
The swissdamed registration obligations are approaching. Companies that structure, validate and technically prepare their UDI data at an early stage reduce later risks, correction loops and operational bottlenecks.
Your first step towards efficient swissdamed compliance:
Please complete the form to request an offer
Invest now in a structured regulatory data strategy for Switzerland.
The swissdamed UDI Excel template is developed and distributed by Europe IT Consulting GmbH, your certified partner for regulatory IT solutions since 2011.
