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 an organization’s quality management system.
The document provides non-binding recommendations to be considered by the medical device manufacturers and other parties involved in operations with medical devices. It should not be construed as an official EC document. The present article describes specific aspects addressed in the present guidance notice issued by the MDCG in July 2021. In particular, the scope of the document covers how the UDI system should be used.
Serious Incidents and Field Safety Corrective Actions
As prescribed by the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR), the UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87 and Article 82, respectively. The particular procedures to be followed by the responsible entity should be described in the appropriate internal policies.
If the elements of the components purchased fall outside the scope of the UDI framework, the responsible entity should duly review the purchasing procedures paying special attention to the following aspects:
- First, medical device manufacturers should rigorously assess the materials they are purchasing in the context of their use in relation to the UDI system. For instance, this applies to the materials and equipment intended to be used to produce labels placed on medical devices and their packaging.
- Apart from this, the responsible entity shall conduct the appropriate investigation with regard to any components and devices already placed on the market which are covered by the scope of responsibility of such party.
- The purchases of any and all elements falling within the scope of the UDI regulatory framework should be duly documented.
Documentation and Records
According to the present guidance notice published by the MDCG, the Basic UDI-DI of a medical device should be placed on:
- The Vigilance and Post-Market Surveillance Reports (such as MIR and PSUR);
- The EU Declaration of Conformity (Annex IV MDR/IVDR);
- The technical documentation (Annex II MDR/IVDR);
- –he Summary of Safety and Clinical Performance (Article 32(2) MDR, Article 29(2) IVDR);
- – The Certificate of free sale (Article 60 MDR, Article 55 IVDR);
- – And certain types of EC Certificate, i.e. EU technical documentation assessment certificates (Annex IX MDR/IVDR), EU Type-examination certificates (Annex X MDR/IVDR) and EU product verification certificates (Annex XI MDR/IVDR). The UDI shall be included on the implant card, in accordance with Article 18 of the MDR. Internal procedures should reference the appearance of the Basic UDI in the abovementioned cases.
It is also stated that the unique device identifier of a medical device should be included in the labels placed on the medical device itself (in the case of direct marking) and/or in the labels placed on the packaging. Additionally, it should also be referenced in the technical documentation accompanying the device. The MDCG also mentions that the Basic UDI-DI and UDI-DI should be included in the new Union-wide database related to medical devices – EUDAMED.
UDI Data to be Provided to EUDAMED Database
The guidance notice further describes in detail the scope of information to be provided to the aforementioned database. In accordance with the provisions of the Regulations (MDR and IVDR respectively), any and all medical devices intended to be marketed in the EU should be included in the appropriate database, unless such devices are covered by the scope of any of the exemptions (e.g., custom-made devices or those intended for investigational purposes or performance studies). In particular, the UDI-related information associated with the medical device should be uploaded to the appropriate UDI section of EUDAMED. Moreover, the medical device manufacturer as a party responsible for a medical device would be further obliged to ensure the information included in the database is relevant and up-to-date and also update such information once necessary.
QMS Process Implementing UDI at the Manufacturer’s Site
The document further describes the particular way the UDI system should be implemented by medical device manufacturers. In particular, the guidance outlines the steps to be performed by the responsible entity in order to achieve and sustain compliance with the applicable regulatory requirements.
These steps include the following ones:
Plan for product traceability. In the course of implementation of the MDR/IVDR requirements related to traceability, the responsible party shall consider the following aspects:
- Legal requirements;
- Internal production process needs that could be impacted by the implementation of the UDI;
- Facilitation of compliance of other stakeholders (including the different logistic pathways);
- Liability aspects;
- Patient needs.
UDI assignment process. First, the medical device manufacturer shall duly identify any and all products, devices, and components thereto that are subject to UDI requirements. According to the document, this applies to all products placed on the market for which the entity is responsible as a manufacturer. The procedures implemented by the entity should describe how the uniqueness of the unique device identifier assigned to a medical device would be achieved. All training carried out by the responsible entity in order to familiarize its staff with UDI-related regulatory requirements should be duly documented, and the appropriate records should be duly kept to be provided to the authority upon request. It is also stated that the manufacturer should review the production control method used with each device to allow one of the following production identifiers: serial number, lot number, expiration date, manufacturing date (only required if this is the exclusive PI), software version.
Placing UDI Carrier and direct marking. The MDCG emphasizes that the way the label should be placed on a medical device should comply with the applicable regulatory requirements set forth by the Regulations. This applies, in particular, in the case of direct marking, when the label is placed directly on a medical device itself, provided it does not impact the use of a medical device for its intended purpose. Such a label should be durable enough to remain clearly visible after numerous use cycles within the whole projected lifecycle of a medical device, even after special cleaning and decontamination/disinfection procedures are required between uses. This factor should be considered by the medical device manufacturer when deciding on the material to be used for such labeling and also on the methods used to produce it.
- The label placed on the medical device should contain all information to be communicated in this way as prescribed by the current legislation.
In summary, the present guidance notice issued by the MDCG addresses additional aspects to be considered by the medical device manufacturers with regard to the way the information should be placed on a medical device itself or its labeling. The document also covers the aspects related to the medical device databases and information to be included therein.
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