Becoming effective in May 2021, the European Medical Device Regulation (MDR) may currently draw most attention to Unique Device Identification (UDI), but did you know that UDI will become a global challenge? Because of the changing requirements and timelines of existing authorities as well as new authorities following with their own UDI regulations, global UDI compliance is becoming a moving target and your UDI project will evolve to an ongoing UDI program.
We already guide mid-size and large enterprises on their way to global UDI compliance and are ready to accompany your journey as well – regardless of whether you have already started to build your UDI program or whether you are starting your UDI processes from the very beginning. The implementation project for our UDI data governance and submission solution, i.e. the UDI Platform, does not only concern the integration itself, but starts with the definition of a strategy for your global UDI setup based on an analysis of your already established processes, and continues as managed service while operating the UDI Platform to support you in maintaining continuous compliance.
In order to handle your evolving UDI Challenge, setting up a strategic UDI program as well as implementing an flexible and extensible framework capable of handling multiple agencies will be unavoidable on your journey to global UDI compliance.
Before setting up your UDI program, several strategic considerations must be made.
Once you have defined your Rollout process to address new markets and their requirements, you need to find a strategy to handle new UDI requirements, while keeping a validated state. Therefore, to get started with your pre-defined Rollout activities, a set of UDI data governance reference processes is required, which should be aligned with your chosen software for UDI data governance processes and Validation Strategy.
Your project structure should be set up in a flexible way, so that you can implement new authorities’ requirements directly into your project plan. We recommend setting up your UDI program with multiple phases in a flexible order based on the business requirements of your regulatory affairs department.
Typically, you as a MedTech company have already set up a project with regard to a Medical Device Regulation such as the EU MDR and are conducting a general Gap assessment of which UDI should be an integral part as it forms the foundation of those regulations. If you need help with such a Gap assessment, we are ready to help you with our template-based approach and our excellent partners with their great experience.
The implementation project of our UDI Platform typically consists of two main phases. First, we focus on the business perspective and then on the technical perspective, followed by ongoing support operations. As UDI will become an ongoing program with numerous implementation projects for different regulatory authorities and their regulations, the phases of several projects will merge into one another, resulting in a cycle that is always surrounded by your quality assurance activities.
Within the Business stream, we start with a UDI requirements analysis. During this phase, we evaluate your established processes, analyze your requirements with regard to EU MDR, FDA and upcoming regulations. In addition to the technical system landscape, we examine your existing master data status in order to see what is missing in your organization.
All results form the basis for the Business Design phase, in which the To-be-processes for UDI related data governance are designed to the needs of your organization and, if necessary, the organizational change management is triggered. The main focus lies on the definition of the master data strategy for the future in accordance with the To-be-architecture.
Based on this Blueprint, the Technical Design can be tackled within the Technical/Integration stream. The workflows are designed to match your process design, the user interfaces are tailored to the needs of your business users, and the data interfaces to your ERP – often SAP-driven – are designed according to the existing technical IT setup. An important step is the user, role and authorization concept, while our solution is usually integrated into your existing Identity Management System.
After we have provided the UDI Platform in the actual implementation phase, the previously designed configuration steps are conducted. The test phase includes functional tests, integration tests and finally the User Acceptance Test (UAT).
In addition to the implementation and testing phase, we offer end-user and IT trainings to prepare a successful experience for your users. After a successful Go-live, we usually plan a Hypercare phase to ensure a smooth transition to your operations. The Hypercare phase is followed by various support activities within our managed service approach to help you maintain continuous compliance.
All phases are surrounded by your validation activities according to your Validation Master. If you need assistance in introducing a new Cloud Solution in your validation activities, our excellent partner network can support you.
