ISO 13485, clause 4.2.3 Medical Device File
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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.
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
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).
And if I am a 3rd party logistcs provider (fulfilment service provider under the EU/MDR), then what is it that I need to do to comply to this clause?
You need to have EC certificate and ISO 13485 certificate from the original manufacturer, Instructions of use especially for the storage and logistic part, any specific requirement regarding the disposal (if applicable).
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Jan 17, 2025