The Egyptian Drug Authority (EDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the unique device identification (UDI) requirements for medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory framework, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, it is also important to mention that provisions of the guidance are non-binding, and could be subject to changes reasonably necessary to reflect the changes in the relevant legislation.
The document provides an overview of the applicable regulatory requirements for various types of medical devices and describes the measures implemented to ensure the safety and traceability of products allowed for marketing and use in the country.
The guidance describes, inter alia, the requirements to be applied to configurable medical devices. Under the general rule, the appropriate configurable device UDI should be assigned to these products before they will be made available to customers. At the same time, the authority mentions that an identifier should be assigned to medical device parts only, while for other components identifiers are not required. The configurable device identifier itself should be placed on the element of the device that will not be subject to changes within the whole period the device is used. It is also stated that an alternative approach could be applied: the identifier could be provided in an electronic format instead of placing it on the label. In such cases, the label of the device and its operating interface should clearly describe the way it could be accessed.
Should some of the elements or components of a configurable device be designed in a way allowing them to be removed and used separately (with another device), they should have their identifiers and comply with other UDI requirements respectively.
The document also provides additional clarifications regarding the regulatory status of combination products and components thereto. In particular, the authority states that when a device is placed on the market or put into service, incorporates a substance which, if used separately, would be considered to be a medicinal product, and as per EDA regulation and authorization the medical device(s), and/or its accessories, shall meet the UDI requirements. Hence, such products shall bear the unique device identifiers as prescribed by the general requirement.
Accessories to Medical Devices
The guidance additionally covers the aspects related to accessories to medical devices and regulatory requirements associated thereto. According to the guidance, if an accessory is supplied separately, or could be installed or removed by a customer, such an accessory should have a separate unique device identifier and comply with respective regulatory requirements.
The authority emphasizes that accessories that significantly change the intended purpose, safety, or performance of the device shall, for UDI, be considered a remanufacturing operation – and as such subject the entire device to a new UDI-DI.
Under the general rule, for single-use medical devices, a direct marking is not required, provided such devices are labeled and packaged individually. This rule applies in case medical devices in question are:
- All of the same version or model,
- Distributed together in a single package,
- Stored in that package until removed for use,
- Not intended for individual distribution, and
- Not implantable devices.
In the case of such products, the primary unique device identifier should be placed on the package. Furthermore, a Unit of Use DI should be duly assigned to the unmarked individually labeled and packaged devices.
Kits and Procedure Packs
The document also describes the rules to be applied in the case of medical device kits and procedure packs. According to the guidance, each medical device kit should have its identifier containing both DI and PI elements describing a specific combination of products. The information about all medical devices included in a kit, irrespectively of whether they are placed on the market separately or not, should be entered into the database, except the cases when such devices are:
- Individual single-use disposable products used only as a part of a respective medical device kit or procedure pack, or
- Exempted from UDI requirements for other reasons.
Medical Devices Marketed at Retail
A specific approach should be applied concerning medical devices that are intended to be sold at retail (retail points of sale). The information required for such devices includes the UDI-PI(s) and other details placed on the point of sale package. At the same time, a full unique device identifier should be placed on higher levels of packaging, which are not intended for retail distribution. Should a medical device be initially intended for both types of use (clinical and retail), both retail and full identifiers should be placed on the labeling respectively?
White Label Products
According to the applicable regulatory requirements, an entity that places a label on a medical device is considered to be its manufacturer and will be fully responsible for ensuring compliance with the UDI requirements, even if a medical device itself is manufactured by a different entity (third party).
Relabeled, Repackaged, Remanufactured, and Services Devices
Under the general rule, for relabelled, repackaged and remanufactured devices new unique device identifiers are required. The new UDIs should be placed instead of the initial ones to identify the entity conducting these operations. A new identifier should comply with any applicable regulatory requirements. At the same time, the authority explicitly states that an entity undertaking relabelling, repackaging, or remanufacturing of a medical device is obliged to keep a record of the initial identifier.
If the device is being serviced and then returned to the initial user, a new identifier is not required, while in case there is an option that the device will be made available to a user different from the initial one, UDI requirements should be fulfilled.
In summary, the present EDA guidance outlines the regulatory requirements for unique device identification to be applied for various types of medical devices. The document highlights the most important aspects to be considered concerning the information to be provided, and the particular way it should be provided in the context of the nature of the device and its specific features.
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