In recent years, Unique Device Identification (UDI) regulations have been a focus topic for global health authorities. These regulations enhance patient safety, improve supply chain management, and facilitate efficient medical device recalls. Read on for a recap of recent updates and expected changes to UDI regulations from global health authorities:
USA:
In 2022, the FDA issued a final guidance document clarifying the requirements for direct marking UDIs on medical devices. This guidance provides manufacturers with recommendations on the appropriate methods for directly marking devices, ensuring the UDI remains legible throughout the device’s lifecycle.
European Union:
The European Commission (EC) has a draft roadmap for the EUDAMED UDI timeline that includes the following milestones:
- Q4 2024: Mandatory use of the database for actors registration, clinical investigations, performance studies, vigilance, and post-market surveillance
- Q2 2026: Mandatory use of the UDI/Device registration module
- Q4 2027: Mandatory use of the Actor, Market Surveillance vigilance, and CIPS modules
- Q2 2029: Mandatory use of the UDI & Device, Certificates modules
Canada:
In June 2021 Health Canada published a Proposal to Introduce a Unique Device Identification (UDI) System for Medical Devices in Canada. The proposed plan indicates all medical devices except Class I and custom-made devices will need to comply with UDI requirements including UDI product labelling and UDI data reporting to a Health Canada database. Implantable medical devices will also need to include UDI data in patient information leaflets and on implant registration cards. Health Canada plans to create a new UDI Database (English and French) or modify the existing Medical Devices Active Licence Listing (MDALL) database. The UDI requirements would be phased-in by risk class, but no implementation timeline or compliance dates have been published.
Australia:
The Therapeutic Goods Administration (TGA) has introduced new UDI requirements as part of the Australian Unique Device Identification System (AUS UDI System). Starting September 2023, all medical devices in the Australian Register of Therapeutic Goods (ARTG) must comply with the AUS UDI System, including assigning UDIs and submitting device data to the TGA’s database.
Brazil:
The National Health Surveillance Agency (ANVISA) has established a UDI system called the Sistema Nacional de Identificação de Produtos para a Saúde (SNIPS). The implementation of SNIPS is being phased in, with Class IV medical devices required to comply by January 2024, followed by Class III devices by January 2025, and Class II devices by January 2026.
Saudi Arabia:
The Saudi Food and Drug Authority (SFDA) has introduced UDI regulations as part of the Medical Device Interim Regulation (MDIR). The SFDA’s UDI system aims to enhance patient safety, improve supply chain management, and facilitate effective post-market surveillance. The implementation timeline varies based on the risk classification of medical devices.
These updates highlight the global efforts to establish and harmonize UDI regulations, ensuring consistent standards for medical device identification, traceability, and safety across different healthcare systems worldwide.