Medical Device Technical File

Medical Device Technical File

For all kinds of medical devices, producers must prepare a Medical Device Technical File in accordance with MDR 2017/745 before placing them on the European market (I, IIa, IIb, III). The manufacturer(s) must have and maintain the most recent version of technical documentation, also known as a technical file, at all times for inspection by authorities. The required criteria for a technical file are outlined below.

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