EU Commission EUDAMED Training: Actor, UDI/Devices, & NBs/Certificates Modules
14 April 2026
April “In all other news”: New Team-NB Clinical Guidance, Borderline Manual v5, & more
4 May 2026Table of Contents
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Background
MDCG 2021-24, originally published in October 2021, provides guidance regarding how to classify medical devices under the EU MDR 2017/745. It includes:
- additional context around concepts, e.g., continuous use,
- a general explanation for each of the 22 classification rules,
- practical issues of classification, e.g., how to assess whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous way,
- classification flowcharts based on type of device, e.g., non-invasive vs invasive devices, and
- example devices and their classifications for each of the 22 rules.
The Update
MDCG 2021-24 Rev.1 is available: HERE
Updates were made to:
- Section 2.1 – General Requirements
- Section 3.1.4 – Procedure: ‘surgical’ replaced with ‘clinical’
- Section 3.2 – Application of classification rules: ‘device’ replaced with ‘product’
- Section 4.1.3 (flowchart) – Rule 9 structure revised
- Rule 8 – Table and practical issues updated, including two new notes
- Rule 9 – Practical issues updated
- Rule 10 – Table and practical issues updated
- Rule 12 – Table updated
- Rule 16 – Table updated
- Rule 22 – Table and practical issues updated, including a new note
Note: The table for Rule 2 is also identified as updated in the changelog; however, a side-by-side comparison of the two versions shows no visible difference in content.
Below are the side-by-side changes made to Rules 8, 10, and 22 in MDCG 2021-24. Please review the guidance document for all updates.
