A notified body must approve medical devices just before they may be promoted and sold in the eu Financial Area (EEA) Unless of course These are for investigation applications or Class I non-sterile, non-reusable surgical instruments, and without having measuring functionality devices. The acceptance process calls for the submission of the medical device technical file.
Yow will discover additional information on the requirements for the different kinds of technical documentation within the MDR. Such as:
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Entire labelling and packaging data, which includes single-device revenue and transportation packaging in the event of precise management conditions;
The technical documentation can be quite a submission of a bundle of files in an individual area or possibly a summary document linking to your suitable version of every document inside of a document administration procedure. But contents should include things like:
Why it’s needed: Raw content data is important in medical device technical file preparation since it ensures the protection, biocompatibility and regulatory compliance with the materials employed.
A technical file is required for all devices apart from Course 1 devices, which aren’t sterile and don’t Use a measuring functionality. If you decide to perform having a Notified Overall body, they will very carefully scrutinize your technical files to ensure compliance.
The non-EU providers that have technical documentation are normally large multinationals like Apple, Nintendo and Xiaomi – not modest factories creating personalized-created and personal-label merchandise mentioned on Alibaba.
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This data is important for demonstrating the device is produced continually and meets all applicable basic safety and top quality expectations.
We requested our Medical Device Top quality Advisor partner Sam Shelley which kind of technique she recommends to create out a compliant technical file, although minimising the amount of effort and hard work and disruption involved when you might be audited.
Trying to handle All of this complexity utilizing a paper-primarily based method or some thing like Google Docs can certainly turn out in a multitude of 1000s of files and file names scattered and duplicated across your servers.
The technical file would be the Technical File list of documents that describe an item, device or equipment and reveal which the product is developed in accordance with the requirements in the appropriate directives and rules.
SimplerQMS supplies entirely validated eQMS for medical device firms to streamline good quality management procedures and excellent documentation administration, such as the management of technical documentation.