Application request for CE marking certification – Regulation (EU) 2017/746

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) 2017/745 and also details how to obtain a quote and submit a Formal Application for certification with GMED.

You will also find in this guide the different conformity assessment procedures applicable depending on the risk class, the type of device as well as their corresponding documents to be transmitted as part of your Formal Application request.

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