An example of a medical device technical file typically follows a very well-defined framework and Business to be certain compliance with regulatory prerequisites and streamline documentation processes.
Annex II outlines an extensive list of all the data manufacturers ought to consist of of their technical documentation to demonstrate that their devices are Harmless and productive.
However, it's critical to consult the particular pointers in your products category and relevant directives and/or polices to make sure that your Technical Documentation fully complies with the requirements. Hold the file regularly updated and conduct systematic checks to make certain ongoing compliance.
The purpose of a technical file is to supply evidence that a medical device conforms to regulatory suggestions and supports the CE marking. It really is a comprehensive document that contains all the knowledge important to reveal the security and general performance prerequisites of your device.
In summary, a technical file is needed for many medical devices within the EU, except for Class 1 devices that are non-sterile and do not need a measuring operate.
The equipment regulation calls for the technical file to include, if applicable, the source code or programmed logic of the protection associated program.
No matter what classification your device is or which pathway that you are having, a technical file is critical. You may assume that When you are undergoing a Notified Overall body, they will definitely assessment your file.
In summary, a medical device technical file follows a structured Group comprising many files.
Ordinarily, basic safety critical elements also have a technical info sheet. Your technical file should have a folder that contains all knowledge sheets for the protection critical parts or materials.
Pre-clinical and clinical information are essential elements on the technical file, demonstrating which the device has been through extensive analysis and validation. This knowledge includes information on the device’s overall performance, its possible hazards, and the outcome of medical investigations or reports.
Finish labelling and packaging information and facts, which includes one-unit income and transport packaging in the event of particular administration Medical Device Technical File circumstances
For that reason, it’s crucial which the technical file incorporates the identical identification of the products given that the products’s marking does. The identification of an item shall be carried via continuously in all documentation, labelling, packaging, etcetera.
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