Codes assignment referred to in the implementing Regulation 2017/2185 in the context of a request for certification according to the Regulation (EU) 2017/745

Regulation 2017/2185 defines the codes that notified bodies use. These codes establish their scope of designation for medical devices under EU MDR.

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.

GMED verifies all assigned codes. We check them against your device’s design, intended purpose, and manufacturing processes. This ensures accuracy and coherency.

This guide explains the different code types. It shows you how to assign them correctly. This ensures consistency across your medical device classification.

We based this guide on MDCG 2019-14 (December 2019). This document provides explanatory notes on MDR codes.

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