UDI Regulations in Europe
The Medical Device Coordination Group (MDCG) has released a July 2021 guidance document “Leitfaden zur Integration der UDI in das Qualitätsmanagementsystem einer Organisation (MDCG 2021-19 )” was issued.
This guidance document describes considerations for manufacturers in incorporating the UDI system into their QMS.
Article 10(9)(h) of the MDR and Article 10(8)(h) of the IVDR stipulate that “confirmation of the UDI assigned to the device and assurance of the consistency and validity of the information registered in EUDAMED” must be incorporated and addressed in the quality management system (QMS) of the manufacturer and others.
This guidance document is intended to provide guidance to manufacturers and others in fulfilling the above obligations.
The assignment of UDI (UDI-DI + UDI-PI) and basic UDI-DI, as well as the management of UDI-related information, can impact many other life cycle QMS processes.
As a means to ensure that the correct assessments/decisions are made and appropriate documented evidence is generated to ensure compliance with regulations regarding UDI systems, manufacturers can establish a plan for UDI implementation and use the appropriate measures specified in the QMS.
This guidance document provides clarification on the following issues to consider in incorporating UDI obligations into the QMS
- design development
- Product documentation and retention
- Critical Incidents and Market Safety Corrective Actions
- Purchase Management
- Documentation and Records
- Providing UDI data to the EUDAMED database
In the Annex (Annex), specific considerations for incorporating processes for UDI implementation into the QMS and examples of UDI implementation plans are provided.
-Table of Contents
Integration of UDI in the Quality Management System
Design and Development
Product documentation and retention
Production and process
Serious incidents and field safety corrective actions
Purchasing controls 購買管理
Documentation and records
Enterprise Resource Planning Enterprise Resource Planning
UDI data to be provided to EUDAMED database UDI data to be provided to EUDAMED database
Appendix I – QMS process implementing UDI at the manufacturer’s site
Plan for product traceability
UDI assignment process UDI assignment process
Placing UDI Carrier and direct marking Placing UDI Carrier and direct marking
UDI linkage to applicable quality records UDI linkage to applicable quality records
UDI information in EUDAMED UDI information in EUDAMED
Annex II – Example of UDI Implementation Plan UDI実施計画の例
Auditing the implementation of the UDI system
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