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Customized medical device packaging materials
Based on the information provided:
– This is a packaging material for medical devices.
– It is customized, which means it is designed specifically for a particular medical device.
Referring to the Medical Device Rules, 2017 (MDR 2017) for classification:
As per the Basic Principles and parameters for classification of medical devices in MDR 2017:
1. The intended use/purpose of the device: The intended use of this customized packaging material is to protect and contain the medical device, ensuring its sterility and integrity until use.
2. The level of invasiveness and the duration of use: This is a non-invasive device that comes in contact with the medical device, but not directly with the patient.
3. The risks the device may pose to the patient: The risks associated with this packaging material are relatively low, as it is not directly in contact with the patient. However, improper packaging can potentially impact the sterility and safety of the contained medical device.
Comparing this with the notified devices in the reference list, I could not find a similar device.
Based on the above analysis, the most likely class for this customized medical device packaging material is Class B.
The reasoning is that the packaging material, while not directly in contact with the patient, plays a critical role in maintaining the sterility and safety of the medical device. Therefore, it is classified as a medium-risk device under Class B as per the MDR 2017 guidelines.