Discover key regulatory updates from the week of November 25th in medical devices, IVD, SaMD, pharmaceuticals, biotech, and combination products, as recognised by the Global Index powered by Hoodin. This edition highlights top regulatory news and analyses, featuring updates from Directorate-General for Health and Food Safety (EU) on a new guidance on the implementation of the Master UDI-DI solution for contact lenses and FDA (US) on a new policy for ethylene oxide sterilisation facility changes for class III devices.
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Top Picks for November 25th - December 1st
MDCG 2024-14: Guidance on the Implementation of the Master UDI-DI Solution for Contact Lenses Directorate-General for Health and Food Safety Published Nov 26
Europe | MEDICAL DEVICES | COMBINATION PRODUCTS
SUMMARY
This guidance outlines the implementation of the Master Unique Device Identifier (UDI-DI) for contact lenses under the EU's Medical Device Regulation (MDR). It applies to both standard and made-to-order (MtO) contact lenses and aims to simplify traceability and identification by grouping highly individualised devices with similar clinical and design parameters under a single Master UDI-DI. The regulation ensures manufacturers comply with enhanced identification, labelling, and registration standards through the European Database on Medical Devices (Eudamed).
Key Implications:
Enhanced Traceability: The use of Master UDI-DIs facilitates improved post-market surveillance and vigilance reporting by allowing grouped identification for devices with similar design characteristics.
Compliance Requirements: Manufacturers must implement the Master UDI-DI system by 9 November 2025. Early adoption is encouraged, and all devices must be registered in Eudamed by the mandatory deadline.
Operational Adjustments:
Manufacturers need to align labelling, packaging, and data management systems with the UDI-DI requirements.
Vigilance reporting must include the full UDI (Master UDI-DI + UDI-PI) to ensure accurate identification of involved devices.
Streamlined Reporting:
The Master UDI-DI simplifies reporting by reducing the complexity of assigning numerous individual UDI-DIs for variations of contact lenses.
Legacy devices can continue using alternative identifiers but must transition to the Master UDI-DI system for new registrations.
Market Readiness: Manufacturers targeting the EU market must ensure compliance with UDI requirements to maintain market access and avoid regulatory non-compliance.
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
FDA | Published Nov 26
North America | MEDICAL DEVICES
SUMMARY
The FDA's guidance, announced on 26 November 2024, outlines a transitional enforcement policy aimed at addressing disruptions in the sterilisation of Class III medical devices using ethylene oxide (EtO). This policy allows manufacturers to seek FDA enforcement discretion when making sterilisation site changes due to potential or actual interruptions at EtO facilities. The guidance intends to mitigate supply chain issues, maintain device availability, and ensure the continued supply of sterile medical devices during compliance transitions.
IMPLICATIONS:
Supply Chain Continuity:
Manufacturers can adapt to EtO sterilisation facility disruptions without immediate penalties, ensuring critical medical devices remain available to patients.
Regulatory Flexibility:
The policy allows for temporary adjustments in sterilisation processes while maintaining safety and effectiveness standards, providing flexibility for manufacturers navigating facility changes.
Compliance Requirements:
Manufacturers must notify the FDA of changes and demonstrate that these changes do not compromise product safety or effectiveness. This ensures a balance between flexibility and accountability.
Impact on Class III Devices:
Focuses specifically on high-risk devices (Class III) that rely on EtO sterilisation, a prevalent method critical to ensuring sterility.
Public Health Priority:
By reducing the risk of supply shortages, the policy supports public health during periods of sterilisation facility transitions or disruptions.
* Top picks may not be the biggest news, as those updates might have already reached you. Instead, the top picks highlight the most important developments for key players in the life sciences industry that you may have missed during the week.
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