August 19, 2020
The European Commission published an updated FAQ document detailing implementation of a Unique Device Identification (UDI) system, which will be mandatory when the MDR and IVDR take full effect in May 2021 and 2022 respectively. Among other intended benefits, the UDI system is intended to make medical devices and IVDs easier to trace and monitor for effective post-market surveillance activities. The EU approach is based on international definitions and standards drawn up by the IMDRF in order to support compatibility among trade partners.
Revised timelines reflect MDR and EUDAMED implementation delays
Of note are the revised timetables featured in this FAQ. In addition to incorporating the postponement of MDR implementation until 2021, the updated document also reflects the implementation delay of EUDAMED, the EU medical devices database, which was announced in October 2019.
Submission of UDI data to EUDAMED will now be mandatory starting on November 26, 2022 for medical devices and on the same date in 2023 for IVDs, although there is a provision to delay this requirement if the database if not fully functional by the date of application of the pertinent Regulation. The FAQ also includes a table that specifies when manufacturers must begin placing the UDI carrier on labels or performing direct marking of reusable devices, broken down by device class.
Other UDI questions cover exemptions, label guidelines, and designation of issuing entities
In addition to compliance deadlines, the FAQ addresses a wide range of questions that manufacturers may have about UDI application. Of the 16 questions included in the document, some representative examples are:
- What is the UDI?
- Which products are subject to the UDI system?
- Who is responsible for placing the UDI carrier on the device itself, on the label and on the package of a device?
- What is the role of the UDI issuing entities? Who designates them?
- How should a UDI appear on the label or package of a device?