Last week, my colleague in the UK, Ed Palferman, got a first glance at the text of the proposed Unique Device Identification (UDI) regulation for the European Union (EU). The language regarding UDIs for medical devices is contained in a larger document known as the Medical Device and In Vitro Diagnostics Regulation (MDR) document. The regulation is expected to be formally adopted by the end of the year, with compliance for the sections related to medical devices in 2020 and for in vitro diagnostic sectors two years later.
So what does the proposed regulation say about UDI and how does it compare with the U.S. FDA rule? While not an exhaustive nor formal legal review, here are a few things I discovered reading the text this week:
1) Global manufacturers will be pleased that European regulators want to follow the guidelines of the International Medical Device Regulatory Forum, recognizing that consistency among UDI rules around the world will help promote patient safety and global trade.
2) European regulators believe UDI is the foundation for better medical device traceability, which they say can deliver myriad benefits, including improved incident reporting, reduced counterfeiting, and improved purchasing and inventory management.
3) Before selling a medical device (other than a custom-made device) in the EU, manufacturers must ensure their products are in compliance with the UDI regulation.
4) At its core, the regulation is very similar to the U.S. rule, requiring manufacturers to: 1) assign a UDI to their products using codes from an authorized issuing agency; 2) label their products with those codes in human and machine readable formats; and 3) publish data about those products to a UDI database.
a. Specific timelines by device class have not yet been established, but the regulation calls for starting with the highest risk class, e.g., implantables.
b. The draft regulation says the European Commission will designate one or more issuing agencies, but it did not specify which organizations other than to say they must provide a “globally accepted device identification and coding standard.”
5) Like the U.S., the UDI will include both a device identifier (DI) and a product identifier (P), e.g., serial numbers, lot/batch numbers, manufacturing and/or expiration dates.
a. The basic DI is assigned at the unit of use, with additional DIs assigned at higher packaging levels, if applicable.
b. Shipping containers do not require a UDI.
c. Exactly what is required in the PI may vary depending on the risk class of the device.
d. If the lot number, serial number, software identification or expiration date appears on the label, it will be part of the PI.
e. If there is a manufacturing date on the label, it does not have to be part of the PI unless the manufacturing date is the only production information on the label.
6) The UDI database will make core data about the products accessible at no charge to the public and enable uploads and downloads of data.
7) The database must support languages required by the European Union member states where the product is sold.
8) Unlike the U.S. FDA rule, the proposed European regulation includes requirements that health institutions store, ideally electronically, the full UDIs (device and production identifiers) for all Class III implantable devices that they have received. The regulation leaves open the possibility that member states could also require health institutions to keep UDIs for all devices supplied to them.
9) For implantable devices:
a. The UDI must be on the lowest level of packaging and must include the full UDI
b. The PI must include the serial number for active implantable devices; other implantable devices can include the lot or serial number in the PI.
c. The UDI must be identifiable before the product is implanted into a patient.
10) The machine readable portion of the UDI on the product or label can utilize a variety of carriers, including linear bar codes, 2D/Matrix barcodes and RFID.
a. If a manufacturer uses RFID as the data carrier, a linear or 2D/Matrix barcode must also be included on the label.
b. The UDI carrier must be placed in a manner that enables it to be easily accessed during normal operation or storage of the product.
c. The data carrier can also include other information beyond just the UDI, such as data to operate the device.
11) A new UDI is required for a product when any of the following changes:
a. Brand name or trade name
b. Device version or model
c. Labelled as single use
d. Packaged sterile
e. Need for sterilization before use
f. Quantity of devices provided in a package
g. Critical warnings or contraindications: e.g., containing latex or the plasticizer DEHP
12) If a manufacturer repackages or relabels a device, it must keep a record of the original equipment manufacturer’s UDI for that device.
As we have learned in the U.S., many of the intricacies of complying with the UDI rule are discovered in the implementation process, especially given the many types of medical devices on the market and the large number of manufacturers. The good news is, many of the challenges are the same in the U.S., and we can share lessons learned. One such means will be through a new Learning UDI Community being organized in the U.S.
The Association for Healthcare Resource and Materials Management (AHRMM) is creating a Learning UDI Community which will include a repository of best practices around UDI implementation and adoption. Let me know if you are interested in participating as an at-large member of the LUC. Also, I welcome your thoughts on the new EU draft regulation. And check the Healthcare Hub in the future for further developments in UDI in the U.S. and the EU.