# Conformity Assessment Processes for Medical Devices in Compliance with EU MDR 2017/745
## Introduction
The European Union Medical Device Regulation (EU MDR) 2017/745, which came into full effect on May 26, 2021, represents a significant overhaul of the regulatory framework governing medical devices in the European Union. The regulation aims to ensure a high level of safety and performance for medical devices, while also fostering innovation and improving transparency. One of the key components of the EU MDR is the conformity assessment process, which manufacturers must follow to demonstrate that their medical devices meet the essential safety and performance requirements before they can be placed on the EU market.
This article provides an overview of the conformity assessment processes for medical devices under the EU MDR 2017/745, including the classification of devices, the role of Notified Bodies, and the steps involved in obtaining CE marking.
## 1. **Device Classification under EU MDR**
The first step in the conformity assessment process is determining the classification of the medical device. The EU MDR classifies medical devices into four main categories based on the risk they pose to patients and users:
– **Class I**: Low-risk devices (e.g., bandages, non-invasive instruments).
– **Class IIa**: Medium-risk devices (e.g., dental fillings, diagnostic ultrasound).
– **Class IIb**: Higher-risk devices (e.g., ventilators, infusion pumps).
– **Class III**: Highest-risk devices (e.g., pacemakers, heart valves).
The classification of a device is determined by its intended purpose, duration of use, and the degree of invasiveness. The classification rules are outlined in Annex VIII of the EU MDR. The higher the risk class, the more stringent the conformity assessment process.
## 2. **Conformity Assessment Routes**
The EU MDR provides several conformity assessment routes depending on the classification of the device. These routes are designed to ensure that the device meets the General Safety and Performance Requirements (GSPR) outlined in Annex I of the regulation. The main conformity assessment procedures are:
### a. **Self-Certification (Class I Devices)**
For Class I devices that are non-sterile and do not have a measuring function, manufacturers can self-certify their products. This means that the manufacturer is responsible for ensuring that the device complies with the relevant requirements of the EU MDR without the involvement of a Notified Body. The manufacturer must prepare a technical file and a Declaration of Conformity, which states that the device meets the applicable requirements.
### b. **Notified Body Involvement (Class Is, Im, IIa, IIb, and III Devices)**
For Class I devices that are sterile (Is) or have a measuring function (Im), as well as for all Class IIa, IIb, and III devices, the involvement of a Notified Body is required. A Notified Body is an independent organization designated by an EU member