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.
In order to determine whether the request for certification within the framework of a CE marking according to Regulation 2017/745 is eligible compared to 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 coherency in view of the design and intended purpose of the device and 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 the consistency of the codes assigned to a type of medical device.
This guide is based on the document MDCG 2019-14, Explanatory note on MDR codes of December 2019.