UDI - Unique Device Identification
In Europe, the introduction of the Medical Device Regulation (MDR) will make a UDI system mandatory for all manufacturers of medical devices. The transition period ends on 26.05.2020.
What does this mean for manufacturers?
The UDI system was developed in the USA, initiated by the Food and Drug Administration (FDA) and is designed to improve patient safety, simplify product recalls and improve market surveillance.
Medical devices must bear a globally unique product number. This must be machine-readable (e.g. bar code) and affixed to the product itself and/or the packaging. The UDI database (UDID) contains this code and can be used to call up various information on the medical device in question. These contain important manufacturer and product information as well as master data entries of the manufacturer:
- Quantity per package
- alternative or additional identification number(s), if applicable
- Specification of how the product is checked (e.g. via batch number).
- Product number of the usage unit, if applicable.
- the name and address of the manufacturer
- Name and address of the authorised representative, if any.
- GMDN code or internationally recognised nomenclature code
- Trade name/brand name, if applicable
- Model, reference or catalogue number of the product, if applicable.
- clinical size, if applicable
- additional product description, optional
- Storage and/or handling instructions, if applicable.
- additional trade names of the product, if applicable
- designated as a single use product (yes/no)
- limited number of reuses, if applicable
- Product sterile packed (yes/no)
- Sterilization required before use (yes/no)
- designated as latex-containing product (yes/no)
- designated as DEHP containing product (yes/no)
- URL address for additional information, e.g. electronic data transfer. Instructions for use, optional
- Important warnings or contraindications, if any.
Manufacturers wishing to (also) place their products on the market in the USA have been required to provide UDI data for Class III medical devices since 24.09.2014.
In the course of the MDR, this will become mandatory in Europe for:
- Class III and implants as of 26.05.2021
- Class IIa and IIb as of 26.05.2023
- Class I as of 27.05.2025
The advantages of UDI:
- Unique, internationally uniform identification of medical products throughout their entire life cycle
- Error-free and fast recording in the production process, warehouse, picking and shipping
- Seamless traceability through more transparency and security
- Facilitated logistics
- Improved handling of device recalls for manufacturers, suppliers and healthcare facilities through standardized product recognition
- Accurate documentation and reporting
- Complicated product piracy through a global and secure distribution chain
Important points to be observed by the manufacturer:
- Class of the medical device
- ISO-based code on products and all packaging levels
- Change of labels necessary?
- Type of data carrier (barcode, data matrix...)
- Where are the required data elements stored and who is responsible for them?
The MDR distinguishes between the two unique device identifiers UDI-DI and UDI-PI:
The primary code (UDI "DI") contains the unique product reference and consists of the fields:
- HIBC System Identifier
- Labelling recognition, globally uniquely assigned code
- Product code: 1 to 18 digits alphanumeric
- Packaging index - indicates the packaging level:
- 0:Usage unit
- 1: smallest sales unit
- 2-8: Multipacks
- 9: variable.
- Primary code for the unique assignment to a UDID database entry
The secondary code (UDI-PI) contains the production data and has a variable structure. It can contain the following fields:
- Quantity: 2 or 5-digit number with unit of measurement in the master data.
- Expiration date in 7 possible machine formats
- LOT: 0 to 18 digits, alphanumeric, blank for no LOT
- Serial number: 1 to 18 digits alphanumeric
- production date
Further information on regulatory requirements and detailed implementation of the UDI Code can be found on the Johner-Institut website.