category

MDR Classification

This document outlines the duration of use of the product along with the regulatory classification of a medical device and a justification why it falls under that specific class according to Annex VIII of MDR 2017/745.
Generate ->

MDR Classification Document

ID: Lorem ipsum dolor sit amet, consectetur adipiscing elit.

Device Duration of Use

Sed ut perspiciatis unde omnis iste natus error sit voluptatem.

Device Classification

Ut enim ad minim veniam, quis nostrud exercitation ullamco.

Device Classification Justification

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Annex I: MDR Annex 2017/745 Annex VIII Chapters 1-3 - Rules and Definitions

Chapter 1: Applicable Definitions

  1. Duration of Use
  2. Invasive and Active Devices

Chapter 2: Implementing Rules

Chapter 3: Classification Rules

4.) Non-Invasive Devices

5.) Invasive Devices

6.) Active Devices

7.) Special Rules

Mapping of Requirements

               

‍

Medical Device Certification Made Easy.