Successfully plan UDI projects
With the unique device identification (UDI) system, the EU is introducing mandatory traceability of medical devices with the publication of the new Medical Device Regulation (MDR) over the course of 2017. UDI will make it possible to identify medical devices of all types and to track them throughout their life cycle. This involves every single medical device (for example, medical equipment, instruments, implants, aids or even medical software) receiving an individual identification number during manufacture that must be applied to the device and all of its (outer) packaging in the form of a machine-readable ISO-compliance barcode. Scanning the codes (instead of an error-prone manual recording) is intended to prevent misuse and simplify logistics and documentation. In this way, product recalls will be simplified and patient safety increased.
The UDI system
The UDI system is made up of several components: on the medical device itself the product data will be applied in the form of an identification number that comprises the elements device identifier (DI) and production identifier (PI) and contains information in coded form such as the date of manufacture, trade name, a batch or serial number and a possible expiry date. This information must be on the label as a barcode and in plain text. The UDI carrier, the second component of the UDI system, is the actual conversion of the information into a machine-readable identification, for example, as a barcode or data matrix. A third component consists of the Unique Device Identifier Database (UDID), mapped over the EUDAMED database of the EU. By scanning the code, the user then accesses certain information that identifies the medical device.
The UDI system in the USA
There has been mandatory UDI labelling in the United States since 2014. Dealing with the US regulations and using the US Global Unique Device Identifier Database (GUDID) has already shown how optimal preparation for mandatory use of the UDI system can work.
It is recommended at the start of the intense dealings with the UDI regulations and directives or the extensive information to use a service provider. A structured project plan to introduce the UDI code for your products should also integrate all the departments in the company that are involved, take into account cooperation with international distribution partners, test coding procedures already in use in the company for suitability for UDI, check distribution and sales regulations for necessary migration, consider internal master data management, consider subsequent validation requirements for the internal IT landscape, plan the selection of the compatible data standard and also consider cooperation with those national organisations that assign the UDI code. The orangeglobal group helps your company throughout the entire planning and introduction processes and completes, if required, manual transfer of the coded data to the EUDAMED database.
UDI projects in medical technology companies
At the start of an internal UDI project, you should ask the following questions within your company: • Organisation: Where will the organisation of the UDI project be located? • Technology/IT/software: Will the existing infrastructure satisfy the UDI requirements? • Master data: for example, is the product name consistent and the same across all functions and is it the same on all packaging units as in the product registration? • Data exchange: Which information has to be entered into the GUDID (Global UDI Database) or EUDAMED or other country-specific databases? • Processes: Are there consequences for the supply chain processes? • Product: Which products fall into which risk classes and are then subject to which deadlines? The publication of the new Medical Device Regulation in the Official Journal of the EU was planned for the 2nd quarter of 2017. Medical device manufacturers have a maximum of three years to adapt their internal processes and to identify their products in accordance with the requirements of the unique device identifier system. The orangeglobal offer: Information about UDI globally The question of how other countries around the world such as Australia, Brazil, China, India, Japan, Turkey, Russia, Saudi Arabia, Taiwan, etc. are handling the UDI and GUDID requirements in their country must be explained separately. In some countries apart from the US UDI-suitable identification numbers and barcodes are already in use. Which deadlines these countries have for the introduction of the binding identification of medical devices depends in part also on the risk class of the medical devices. Requirements differ from country to country. The orangeglobal group provides you for UDI with an inventory for each country and regular country updates and helps you compile the relevant country-specific requirements.
These services may also be of interest to you:
• Risk analysis and risk evaluation to provide evidence of the safety in accordance with DIN EN 62366 and ISO 14971
• Clinical evaluation reports or clinical evaluation in accordance with MEDDEV 2.7.1 Rev. 4
• Clinical trials with a clinical protocol in accordance with ICH-GCP, ISO 14155 and MEDDEV 2.7.1 Rev. 4 for class IIb and III medical devices
• Technical documentation in accordance with current directives and future MDR/IVDR and in accordance with MEDDEV
• National language product information (IfU and eIfU as per EU Regulation 207/2012, labelling)
• CE certification and declaration of conformity
• Internationalisation of medical devices
• Post-market clinical follow-up studies (PMCF) as per MEDDEV 2.12/2 and periodic benefit risk evaluation reports (PBRER)
Your contact person:
Frau Dipl. Biol. Jana Wolkow
Project Manager Regulatory Affairs
Tel. +49 (0) 731 954 95 - 511
jana.wolkow@orangeglobal.(.)de