The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the integration of the UDI within organizations’ quality management systems.
The MDCG explicitly mentions that the document is intended solely to provide additional clarifications and recommendations on the matter and should not be treated as an official document issued by the European Commission and representing its position. All provisions of the present guidance are non-binding in nature and should be considered by parties involved in the context of achieving and sustaining compliance with the applicable regulatory requirements.
According to the MDCG guidance, the Unique Device Identification (UDI) System is intended to:
- Allow the identification of medical devices,
- Facilitate appropriate traceability of medical device,
- Enhance the effectiveness of the post-market safety-related activities for devices,
- Improve incident reporting,
- Enhance targeting field safety corrective actions,
- Lead to better surveillance,
- Reduce medical errors, and
- Help fight against falsified devices.
In order to achieve the goals outlined above, the UDI system should be duly incorporated into all the stages of the life-cycle of a medical device intended to be placed on the market.
The regulatory basics for the UDI system are established by Article 27 of the Medical Devices Regulation 2017/745 (MDR) and Article 24 of the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR). According to the aforementioned regulations, the scope of application of the UDI system should cover any and all medical devices apart from custom-made, investigational, or performance study devices.
The present guidance is intended to provide additional clarifications regarding the approach to be applied when implementing the UDI system and responsibilities associated thereto as part of a Quality Management System (QMS) employed by an organization. The scope of the guidance covers all the parties involved in operations with medical devices, including medical device manufacturers and their authorized representatives, as well as distributors and importers.
The MDCG additionally mentions that other guidance documents dedicated to the matter should be taken into consideration as well.
UDI Integration in the QMS
According to the aforementioned regulations, medical device manufacturers should be responsible for verification of the UDI assignments made in accordance with Article 27(3)/24(3) (for MDR and IVDR, respectively) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29/26. The MDCG further states that the actual implementation of the UDI-related elements could cause a significant impact on the QMS processes employed by the manufacturer. Thus, the manufacturer shall duly develop and follow a UDI implementation plan in order to achieve and sustain compliance with the UDI-related regulatory requirements described above.
According to the guidance, the scope of such a plan should 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.
As mentioned, responsibilities could be assigned to other parties involved in the process, including authorized representatives or distributors).
Implementation: Stages 1-3
The MDCG further describes in detail the most important aspects to be considered by a medical device manufacturer when implementing the UDI system in its QMS procedures. In particular, the document highlights the main aspects related to each sphere, namely:
1.Design and Development. According to the applicable regulatory requirements, a UDI should be duly assigned to a medical device before it is placed on the market, except in cases when a device falls within the scope of specific exclusions mentioned above (e.g., custom-made, investigational, or performance study devices). Such a UDI should meet the applicable requirements followed by the issuing entity duly designated to perform such an activity. Additionally, the manufacturer is also responsible for assigning a Basic UDI-DI. If the device in question is subject to prior conformity assessment, such an assignment should take place before submitting the device for review. As mentioned, the manufacturer shall consider the impact the implementation of the UDI system would have on its QMS processes and procedures. The UDI-PI used should replicate the production identifiers assigned to the device in accordance with the applicable regulatory requirements. The MDCG also mentions that procedures used for the assignment of UDI, the change of UDI, and the corresponding degree of traceability (grouping of devices under a Basic UDI-DI or definition of their UDI-PI) should be appropriately documented.
2.Product documentation and retention. It is stated that the medical device manufacturer is obliged to keep records related to any and all UDIs assigned. Such documentation should be kept for a minimum of 10 years from the date the last device the documentation relates to is placed on the market. In the case of implantable medical devices, this period should be extended for additional five years and constitute 15 years from the date the last device has been placed on the market.
3.Production and process. According to the guidance, medical device manufacturers may also use UDIs for their internal needs. The timelines for application of the UDI requirements are based on the risks associated with the medical device in question and its class under the current EU risk-based classification for medical devices. In order to assist the parties involved, the guidance provides the appropriate schedule. In the case of direct marking, where the information is placed directly on a medical device, certain changes to the manufacturing process could be required, so the MDCG recommends manufacturers considering this aspect in advance. With regard to the labeling requirements in general, the MDCG emphasizes the following:
- Medical device manufacturers should ensure the label printing process is verified and validated;
- In case of any changes to the processes that have been already validated, an additional assessment would be required to evaluate the actual impact such changes would have on labeling;
- The manufacturer should be responsible for ensuring a continuous validated state for the software used in the context of the UDI-related processes and procedures.
In summary, the present MDCG guidance describes how the UDI system should be implemented by medical device manufacturers in their QMS processes. The document highlights the most important aspects to be considered, including the ones related to the labeling and the way it should be placed on a medical device depending on its type and applicable regulatory requirements.
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