account_tree

MDR Classification Document

Use this MDR Classification Document template to determine and justify the correct classification of your medical device according to EU MDR 2017/745 Annex VIII rules. This document is essential for regulatory submissions and must be completed during the design and development phase—before engaging with notified bodies—to ensure your device is accurately categorized and compliant with EU regulatory requirements.
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.