All you need to know about the Technical Documentation

A medical device can only be placed on the European market once the manufacturer declares conformity of the device with applicable EU Regulations. Manufacturers provide evidence for conformity with the applicable regulations with a set of documents that describe comprehensively the medical device, including, among many other aspects, the intended purpose, design, manufacturing, verification and its validation. This set of documentation is called Technical Documentation (TD). The expected content of a TD is set out in the Annexes II and III of Medical Device Regulations EU 2017/745 (MDR)1 and EU 2017/746 (IVDR).

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