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Improving Technical Documentation for Devices for Clinical Investigation in the EU

This article was originally published in RAJ Devices

Executive Summary

Prior to conducting a clinical investigation of a non-CE-marked medical device in the European Union, a manufacturer must prepare as fully as possible technical documentation to show that the product conforms to the requirements of Directive 93/42/EEC concerning medical devices (MDD)1. The documentation can then be updated later on.

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