European Union UDI Requirements
Utilize the HIBC Standard for European Labeling
The HIBC Supplier Labeling Standard has been used globally for over 30 years. The HIBC standard allows labelers to use the same barcode world-wide. HIBCC is working closely with regulatory bodies and labelers to ensure all HIBC UDIs meet the EU MDR requirements.
If you need to create a UDI, first apply for an LIC assignment by submitting an application online or offline. If your organization already has an LIC, you can create, calculate, and confirm UDIs with our new UDI-Builder. To contact HIBCC for more information on EU labeling requirements, email firstname.lastname@example.org .
European Union Medical Device Regulation (MDR) Labeling Requirements
The European Parliament adopted two new regulations, Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), on April 5th, 2017. The new regulations aim to improve tracking and trace-ability of medical devices, increase patient safety, and create a more transparent environment. The MDR requires all medical devices to bear a UDI.
Generate the HIBC Basic UDI-DI
The HIBC Basic UDI-DI enables manufacturers to connect and identify devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). The Basic UDI-DI is required in the EU’s EUDAMED database and is referenced in relevant documentation (i.e. certificates and technical documentation).
European Union Useful Documents
- HIBC Basic UDI-DI
- Important Notice – EUDAMED Launch Delay
- Guidance on Qualification and Classification of Software
- EU UDI FAQs
- European Union Legislation – Issuing Entity Designation
- European Union Medical Device Regulation
- Guiding Principles for Issuing Entities Rules on Basic UDI-DI
- Guidance on Application of UDI Rules to Device-Part of Products
- Guidance on Basic UDI-DI and Changes to UDI-DI
- Future EU Medical Device Nomenclature
- Guidance on UDI Systems for Procedure Packs
- Definitions/Descriptions and Formats of the UDI Core Elements for Systems or Procedure Packs
- UDI Assignment to Medical Device Software
- Clarifications of UDI Related Responsibilities
- Provisional Considerations Regarding Language Issues Associates with the UDI Database
- Timelines for Registration of Deice Data Elements in EUDAMED
- Implant Card Guidance
- Class I Transitional Provisions
- Guidance on Clinical Evaluation/Performance Evaluation of Medical Device Software
- Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD