Based on the EU declaration of conformity, the subsequent are demanded for a medical device technical file:
Any considerable modifications on the medical device, its intended use, or its production process could involve updating and resubmitting the technical file.
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Regardless of a device class, or its meant use, structure, or perhaps the safety historical past of your device, the manufacturer need to have – and sustain-to-day – this technical documentation, so that you can reveal the compliance with general safety and functionality demands with the laws.
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Together with the PMS activities and experiences, the major change during the technical file is that the predicted top quality of the technical documentation has greater substantially; In particular, In terms of scientific information, which now really should be sturdy enough to duly substantiate any claims3.
If you can find considerable changes in your product or service, course of action or procedures you will have to resubmit your total Medical Device File into the regulator again. At this stage You'll have to produce a brand-new Structure Historical past File that displays and information each of the alterations your solution has passed through.
Class I devices which can be sterile, have measuring functions, or comprise reusable surgical devices are evaluated specifically for those characteristics. Other Class I devices demand a declaration of conformity.
Correctly structured technical documentation is essential for medical device manufacturers. It ensures that regulatory inspectors can Technical File certainly understand the contents of the device’s technical file, and having a nicely-structured construction, it’s easier to update various sections as required.
Here is an summary of the foremost global regulatory bodies associated, and the sort of documentation they desire:
There is certainly not a definitive list of products that need technical documentation. This depends completely about the applicable directives and rules. In most cases although, it can be stated that the following items have to have technical documentation:
On the whole, directives and regulations which include CE marking provisions also involve technical documentation. Here are a few samples of these types of directives and rules:
This critique ensures that the device fulfills all applicable safety and functionality requirements. With out a perfectly-ready and up-to-day technical file, the acceptance procedure might be delayed or simply turned down.