Commission Implementing Regulation 2017/2185 establishes the codes for the definition of notified bodies’ scope of designation in medical devices under Regulation (EU) 2017/745.
To determine whether the request for certification within the framework of CE marking according to Regulation (EU) 2017/745 is eligible regarding the designation codes for which GMED is designated as a notified body, the manufacturer must describe the type of device and technology concerned and identify the corresponding codes.
The assigned codes are then verified by GMED to ensure their consistency with the design and intended purpose of the device, as well as the technologies and processes used.
The purpose of this guide is to clarify the different types of codes and their method of assignment in order to ensure consistency in the codes assigned to a given type of medical device.
This guide is developed based on MDCG 2019-14, Explanatory note on MDR codes of December 2019, complemented by GMED’s experience gained in designation code assignment since its designation under Regulation (EU) 2017/745.
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