MDCG posts guidance on UDI integration within a QMS
The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s quality management system (QMS) to meet requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).The 10-page guidance calls for manufacturers to have a plan for implementing UDI, as assignment of UDI-DI and management of UDI-related processes “can impact many other lifecycle QMS processes.”
“The purpose of this document is to provide guidance on the integration of the UDI and the implementation of the UDI obligations as part of an organisation’s [QMS] as required by Article 10(9)(h) MDR and 10(8)(h) IVDR,” MDCG writes, noting that manufacturers need to consider how the UDI system and related obligations can be integrated into their QMS.
MDCG explains that a UDI implementation plan can help manufacturers make correct assessments and decisions and generate the proper documented evidence to ensure compliance with the regulations regarding the UDI system.
Some potential elements of such a plan include:
- Analysis of expectations and needs of different stakeholders, such as economic operators, healthcare institutions/professionals, patients/users, insurance providers;
- Analysis of the relevant issuing entities’ standards;
- Choice of a designated issuing entity;
- Definition of internal responsibilities for the implementation and subsequent management of the project plan;
- Management and, if necessary, updates of the project plan implementation;
- Description of methods and use cases, by which the proper running and continuous compliance of UDI-related QMS processes can be verified.
For instance, “Manufacturers should consider the objectives and anticipated effects of the UDI system when designing and developing their products. The manufacturer should assure assignment of UDI-DIs prior to placing a device on the market or submitting a Technical Documentation to a notified body for conformity assessment, by using the rules of the issuing entities.” Procedures for the assignment and change of UDI, as well as the degree of traceability should be adequately documented.
Manufacturers are also instructed to keep an up-to-date list of all UDIs they have assigned and keep technical documentation available for the competent authorities for at least 10 years after the last device covered by an EU declaration of conformity has been placed on the market, or for 15 years in the case of implantable devices. Additionally, the guidance encourages manufacturers to decide for each type and model of device to consider when, where and how the UDI carrier will be applied, in line with the timeline provided for different risk classes under MDR/IVDR.
“As the UDI carrier may have an impact on manufacturing processes, in case of directly marked devices, it should be determined in advance if any exemptions in accordance with Point 4.10, Part C of Annex VI apply, to ensure that the requirements are fulfilled at the time the device is placed on the Union market,” MDCG writes.
Additionally, the guidance provides recommendations on procedures relating to reporting serious incidents and field safety corrective actions, purchasing controls, documentation and records, enterprise resource planning, as well as the UDI data that should be submitted to the Eudamed database.
Annexes to the guidance provide a list of steps that should be considered when implementing UDI processes into a QMS, an example of a UDI implementation plan, and recommendations for notified bodies on auditing the implementation of the UDI system.
MDCG
