The machinery regulation involves the technical file to include, if relevant, the resource code or programmed logic of the security relevant computer software.
Catarina Carrão, freelance medical writer on Kolabtree, provides an outline of what a medical device technical file is and what it really should comprise.
A Notified Overall body or regulatory authority audits the file to make sure the device fulfills safety and functionality specifications. The device’s maker is to blame for protecting the technical file and making sure it meets all lawful and regulatory specifications, with certification granted for the device alone.
Retain records up-to-day: Make sure that all info is recent and reflects any structure variations or updates
In the case of Single Use Devices (SUDs), specifically in the chance management documentation, suppliers shall reveal and substantiate why the device is manufactured as a result – that is definitely, it really should clearly be stipulated why the device can't be reprocessed3.
There may be an expectation that a technical file need to be a dwelling doc that is definitely stored inside the standard administration technique, alongside other important artifacts, through the entire whole item lifecycle.
There are lots of criteria harmonised underneath the very low voltage directive 2014/35/EU offering specifications for security of electrical gear, like specifications for audio and video equipment, lamps or switchgear.
In conclusion, a medical device technical file follows a structured Firm comprising a variety of files.
It includes suggestions and issues supplied by end users, information and facts from craze reporting, and applicable specialist or technical literature.
a Periodic Basic safety Update Report (PSUR, for devices increased than Course I, Article 86) or even a PMS report (for devices of Course I, Short article eighty five)three. While in the check out in the regulators, producers should Engage in an Energetic part in the course of the put up-industry stage by systematically and actively Obtain information from submit-marketplace encounter with their devices, to be able to update their technical documentation and cooperate within the vigilance and industry surveillance functions.
Pre-clinical and clinical details are crucial elements on the technical file, demonstrating which the device has undergone thorough evaluation and validation. This knowledge incorporates info on the device’s overall performance, its prospective dangers, and the outcome of scientific investigations or experiments.
The device description and specification during the technical file serve as an extensive overview of your device. This overview offers in-depth specifics of medical device technical file the device’s design, elements, meant use, and general performance qualities.
All these items are sometimes also known as the exterior technical documentation: the documentation and knowledge supposed for that conclusion-consumer on the solution.
Formerly, beneath the old QSR, the FDA broke down technical documentation necessities into 3 collections of files: