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Declaration of conformity: Your official declaration which the device complies with relevant polices.
Although the applicable laws establishes what must be within a technical file, and so the technical file of a toy is different from that of machinery, you will discover particular aspects that overlap.
You can find more info on the requirements for the different kinds of technical documentation while in the MDR. By way of example:
An arranged and well-maintained technical file makes sure that all necessary files and facts could be accessed and current efficiently, supporting ongoing compliance with regulatory needs.
A technical file is needed for all devices apart from Class 1 devices, which aren’t sterile and don’t have a measuring function. If you decide to work with a Notified Human body, they're going to meticulously scrutinize your technical files to make certain compliance.
For that rationale, it’s critical that medical device technical file the technical file incorporates a similar identification from the products as being the product or service’s marking does. The identification of an item shall be carried as a result of persistently in all documentation, labelling, packaging, and so on.
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Packaging facts ought to exhibit the device’s packaging maintains its sterility and safeguards it during transport and storage. This will likely consist of packaging substance specifications, examination success and packaging style documentation.
Why it’s necessary: This area defines the device’s function and scope, making sure it is understood regarding its features, meant people and utilization situations. It can help regulators evaluate the device’s Total match in medical contexts.
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The device description and specification from the technical file serve as a comprehensive overview with the device. This overview provides thorough specifics of the device’s style, parts, supposed use, and overall performance properties.
All these items are occasionally also called the external technical documentation: the documentation and information intended for the close-person with the product or service.
Earlier, beneath the outdated QSR, the FDA broke down technical documentation demands into 3 collections of files: