Prepare technical documentation before placing a product on the market.Įnsure technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market. The EU MDR states that medical device manufacturers must: You can expect that if you are going through a Notified Body, they will definitely review your file. No matter what classification your device is or which pathway you are taking, a technical file is necessary.
It sounds simple on the face of it, but it does mean that you are also responsible for defining the legal framework applicable to your device and identifying which assessments are necessary (tasks that a third party would otherwise undertake). Self-declaration means that your company declares your device has met the required standard. What throws some manufacturers off is that some products classified as lower-risk will have a self-declaration, which does not require the permission of a Notified Body to review a technical file. When is a technical file required? Basically, all types of devices entering the EU marketplace will require a technical file. It’s very much like how a PMA is used for Class III product submissions to FDA. In the EU, the design dossier is used for the higher risk medical devices. One thing to make clear is that the technical file is not exactly the same as a design dossier, which can be seen as slightly more in-depth or advanced than a technical file. A technical file comprises a collection of evidence used in a regulatory submission to demonstrate that a product is safe and effective and that you’ve met the requirements for the CE Mark. A good way to think of it is that it’s analogous to a 510(k) or a regulatory submission to FDA, except with a European twist, if you will. The technical file has been around for a long time.
Texnicle file for free#
Here’s how to structure yours to successfully enter the EU:įREE CHECKLIST: Make sure you're structuring your technical documentation correctly with this helpful checklist that you can download for free by clicking here. If you’re going for a CE Mark, then you need to understand what is required of the technical file. It’s essentially an “everything you must know” document for a device. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. The medical device technical file is a must-have document for devices to be sold in the EU marketplace.
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