What was previously known as the Technical Building File and it is now generally referred to easily because the Technical File or Technical Documentation is actually a compilation of all suitable data demonstrating compliance Using the essential demands of your relevant directives and/or regulations in the creation of your merchandise. This consists of all files and calculations used to structure and Create the product.
Producers are essential by regulation to reveal that they're in compliance with MDR requirements. The MDR Regulation makes use of technical documentation (often often called a “technical file”) to determine that a medical device fulfils the general safety and overall performance standards.
The technical documentation for the devices is important for approval and ongoing inspections. Not just can it be required for offering your devices from the EU, however it’s also matter to scrutiny via the US FDA and ISO 13485:2016 audits.
There may be an expectation that a technical file ought to be a residing doc that is held within the quality administration procedure, along with other vital artifacts, through the entire full merchandise lifecycle.
Why it issues: The technical file is essential for regulatory submissions and industry acceptance, which includes CE marking and UKCA marking.
The specifications for PMS must immediately correspond to the danger associated with the machines, enabling the producer to take corrective or preventive action.
It’s necessary to have an extensive, effectively-documented technical file for your medical devices to be sure compliance with regulations and assurance the safety and effectiveness of your respective solutions.
All electrical and Digital gear have to bear the waste electrical and electronic machines (WEEE) marking. The technical file shall incorporate photos of the products showing the place the WEEE marking is located.
A medical device technical file, also referred to as technical documentation, is a comprehensive assortment of paperwork which contains all the technical details about a medical device.
A controlled Model of the technical file must be readily available all of the time. Non-EU Medical Device brands are needed to hold the file using an Authorised Consultant within the EU for consultation Any time important.
Most directives involve to offer person Guidelines with products and solutions. A duplicate need to be stored from the technical Technical File file. That can be the consumer handbook, installation Guidance, upkeep handbook, security instruction or any other form of Guidance.
Cost-free CHECKLIST: Make sure you're structuring your technical documentation accurately with this beneficial checklist that you could down load free of charge by clicking in this article.
Meticulous scheduling and planning from the technical file suitable from the beginning of your merchandise improvement system is essential. It includes gathering all important details, including device description, effectiveness necessities, technical specs, hazard evaluation, and manufacturing procedures.
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