The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must know” document for a device.

If you’re going for a CE Mark, then you need to understand what is required of the technical file. Here’s how to structure yours to successfully enter the EU.

Technical file overview

The technical file has been around for a long time. A good way to think of it is that it’s analogous to a 510(k) or a regulatory submission to the U.S. Food and Drug Administration (FDA), except with a European twist, if you will. 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.

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