Storage & Handling Condition: Key aspects and their significance
The ever-evolving medical device industry is subject to comprehensive guidelines designed to ensure the safety and efficacy of healthcare products. With the introduction of Unique Device Identification (UDI), medical device manufacturers are required to provide a wide range of product information to authorities such as the FDA or EUDAMED. The “Storage & Handling Condition” forms an integral part of these UDI regulations for medical devices, as it must be included in the information provided on the label.
Storage & Handling Condition are part of the attributes of the UDI-DI. They provide specifications and recommendations for the storage, handling and conditions under which medical devices should be stored, transported and used to ensure their quality, safety and effectiveness. Compliance with these recommendations is critical to ensure that the device performs as intended and does not compromise patient and user safety. Typically, this is specific information about temperature ranges, humidity conditions, light exposure, packaging requirements and storage duration.
Example: “do not cut”, “keep in a closed container”, “avoid contact with water”.
According to the UDIWG 2018-1, they are defined as “Indicates the storage and handling requirements necessary for the product as specified in Annex I, 23.2 (k) of the MDR and Annex I, 20.2 (k) of the IVDR.”
Guideline for filling out Storage & Handling Condition in EUDAMED
When filling out the Storage & Handling Condition in EUDAMED, the following points must be observed:
- The Storage & Handling Condition are presented as a drop-down list of nomenclature codes with description. So you only need to select the correct items. In case where your Critical Warning is in the dropdown menus, it is not necessary to add another language than English. The system does it automatically with the internal code provided by EUDAMED already translated into all languages.
- For some of these types a description is required, which you can enter in the corresponding field.
- You can add several types of storage and handling conditions.
- If the selected type of critical warning is the “Other” option, product manufacturers must enter the description on their own. The description and warning should be provided in English as well as in the languages of the countries where the product is made available (MDCG 2018-7). The Storage & Handling Condition “should be provided in English as well as in the languages of the countries in which the device is made available.” (MDCG 2018-7)
- The Critical Warning is one of the data elements for which any change requires a new UDI assignment (Medical Devices Regulation 2017/745, Annex VI, 3.9).
As a rule, the manufacturer is responsible for providing accurate and up-to-date Storage & Handling Conditions for its products. This data element is extremely significant and should not be underestimated when collecting UDI records.
We have prepared a video that shows you exactly how to add in our EUDAMED Add-On Storage & Handling Conditions:
We have prepared a video that shows you exactly how to add in the EUDAMED Playground Storage & Handling Conditions:
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