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ISO 13485, clause 4.2.3 Medical Device File

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Guest user Created:   Dec 16, 2020 Last commented:   Dec 13, 2022

ISO 13485, clause 4.2.3 Medical Device File

Does a service company who is only transporting medical devices from point a to point b, have to have a Medical Device File, ISO 13485, clause 4.2.3? I won't think so. Isn't this not applicable since they are only transporting goods from point A to point B.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 16, 2020

Clause 4.2.3 is not possible to exclude or mark as not applicable. It means that you need to have the following documents in your Medical device file: CE certificate of the medical device and any special instruction or label about storage and transport conditions. Maybe there are more documents considering the nature of the medical device, but generally, those two documents are enough.

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HS Dec 10, 2022

I understand if I am the device holder but if I am contractor making a medical device component and not the finished device why is this still necessary

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Kristina Zvonar Brkić Dec 13, 2022

In that case, you need to have a medical device file for the component that you produce. This means the specification for this component, if applicable some instructions on how your component is integrated into the final medical device, label, and any other kind of instructions (instructions of use, instructions for cleaning).

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Dec 16, 2020

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