MedTech Consulting

YOUR STARTING POINT

When is UDI consulting useful?

• •New target markets or regulatory databases need to be incorporated into an existing UDI process.
• •Basic UDI-DI, UDI-DI and related product relationships need to be structured or cleaned up.
• •UDI data is spread across SAP, another ERP system, Excel files or multiple databases.
• •Responsibilities across Regulatory Affairs, Quality, master data management, IT and other departments are not clearly defined.
• •Errors only become visible during upload or after submission.
• •Manual entry, XML upload and M2M/Data Exchange need to be assessed for the specific use case.
• •An existing Excel process needs validation, standardisation or migration to a scalable solution.
• •UDI data will be managed and transmitted to target systems directly from the SAP environment.
• •Multiple authorities or target markets need to be served from a shared data foundation.
• •Labelling, barcode and UDI data processes need functional and technical alignment.

CONSULTING AREAS

What does a UDI consulting project clarify?

THE BASIS FOR YOUR DECISION

Four levels for a sound UDI decision

WORKING TOWARDS IMPLEMENTATION

From your starting point to an actionable UDI roadmap

1. 1

   Establish the starting situation and objectives

   First, we collect information on target markets, affected product groups, existing data sources, current workflows and known problems. We also clarify whether a new process is to be established or an existing solution developed further.

2. 2

   Analyse data and processes

   Together, we examine which UDI data already exists, which relationships and authority-specific additions are needed, and where disconnected workflows, duplicate maintenance or late errors arise.

3. 3

   Define the target model and responsibilities

   The target model describes data ownership, maintenance, validation, approval, transmission and feedback. It shows which tasks belong to the manufacturer, a Europe IT solution and the regulatory target system.

4. 4

   Select a solution and transmission method

   Suitable solution components and technical transmission methods are assessed against the requirements. There is no blanket threshold beyond which XML or M2M must always be used. Data structure, recurrence, quality and the operating model matter just as much as volume.

5. 5

   Prepare and support implementation

   The target model becomes a prioritised roadmap. Depending on the project, this covers data cleansing, mapping, validation rules, roles and approvals, technical implementation, testing, submission preparation and knowledge transfer to the teams involved.

CONCRETE PROJECT DELIVERABLES

Typical outcomes of UDI consulting

• ✓defined project scope by target market, product area and records
• ✓overview of existing data sources and authoritative systems
• ✓business data model with shared and authority-specific information
• ✓mapping of Basic UDI-DI, UDI-DI and relevant record relationships
• ✓roles and responsibilities for maintenance, checks and approval
• ✓validation and error-handling process
• ✓assessment of suitable Europe IT solutions and transmission methods
• ✓implementation roadmap with prioritised work packages
• ✓foundation for implementation, testing, data migration and ongoing operation

The specific scope of services is agreed for each project. Functional and technical consulting supports implementation, but does not replace the manufacturer’s regulatory responsibility or final approval.

FROM CONCEPT TO SOLUTION

Suitable Europe IT solutions following consulting

Understanding UDI-DI, UDI-PI and Basic UDI-DI

UDI stands for Unique Device Identification. In practical data processes, identification and production information must be considered separately:

The information that must be maintained, validated and transmitted depends on the market, product type, data model and specific record. Consulting translates these relationships into the manufacturer’s actual product and system context.

• UDI-DI: the static Device Identifier for a specific product or packaging level.
• UDI-PI: the variable production identifiers, such as lot, serial number, manufacturing or expiry date information, where applicable to the product.
• Basic UDI-DI: the central key in the European system for grouping products within the applicable regulatory framework; it does not appear as a label on the product.

GOOD TO KNOW

Frequently asked questions about UDI consulting

THE NEXT STEP

Discuss your UDI starting situation

Would you like to establish or improve your UDI process?

For an initial discussion, information about target markets, product and UDI structures, existing data sources, the current transmission process and key open questions is helpful. This provides a basis for identifying the appropriate next step.

Arrange a discussion about your UDI project.