Cheat Sheet: MDCG Guidance on Medical Device Classification

Publications
Published on:
April 8, 2022
Written by:
Hasma Boudaoui, Mercè Guerra, Ainoa Forteza

Assigning the proper class to a medical device (MD) is one of the most important activities carried out by a manufacturer. The Medical Device Coordination Group (MDCG) (1) released guideline MDCG 2021-244 (2) in October, providing clarification on how medical devices (MDs) should be classified under the Medical Device Regulation (MDR) 2017/745.  

The MD manufacturer is responsible for assigning the proper classification to its MD, as it depends on the product’s claims and functionalities. Incorrectly classifying a MD could significantly impact product development, considering different regulatory, nonclinical, and clinical requirements depend on the classification.  

The MDCG issued this guidance to clarify the classification system under MDR and allow for easier comprehension of the MD classifications. The guidance includes a stepwise flowchart (3) illustrating how each rule should be applied and providing practical examples. 

In the EU, MDs are sorted into four different classes, from low to high risk:  

  • Class I 
  • Class IIa 
  • Class IIb 
  • Class III 

Classification is based on a risk level system that considers the degree of invasiveness, the part of the body affected, the contact duration with the body, and other elements. These elements, along with the intended use of the device, should help manufacturers determine which “classification rules” apply to their device.  

If more than one rule applies, the manufacturer should assign the highest risk class to the device. For example, if both Rule X (Class IIb) and Rule Y (Class III) apply to the device, the device would be assigned the higher one: Class III.  

If the regulatory classification of the device is not clear, or it could be controversial, Alira Health recommends seeking out clarification. Particularly with borderline products, e.g., products that could be seen as medicinal, cosmetics, or food supplements, clarification is important as not properly categorizing the product may have important consequences for its development. 

About Alira Health

The Alira Health Regulatory team provides support to manufacturers on: 

  • Properly classifying a device under MDR through a classification assessment that evaluates the MD’s intended use, target population, and functionality 
  • Identifying which requirements are applicable to your device based on the assigned class, and providing regulatory, operational, and strategic support to commercialize the product  

References

  1. The Medical Device Coordination Group (MDCG) is an expert group, set up by both Medical Devices and In Vitro Diagnostic Devices regulations, respectively 2017/745 and 2017/746, whose members are representing EU competent authorities. Their main objective is to help and guide the European Commission and countries in implementing properly both regulations.
  2. MDCG 2021-24 Guidance on classification of medical devices mdcg_2021-24_en.pdf (mdi-europa.com)
  3. MDCG 2021-24 Guidance on classification of medical devices. Explanations of individual rules: Graphical summary mdcg_2021-24_en.pdf (mdi-europa.com)

 Abbreviation  

  • MD: Medical Devices 
  • MDCG: Medical Device Coordination Group 
  • MDR: Medical Device Regulation 

 

Related news

Multimedia September 29, 2022
Regulatory Strategy for Registering Rare Disease Products in the EU
In this webinar we will focus on how to benefit, today and in the future, from the orphan drug program and build a regulatory strategy for successful rare disease product registration(...)
Drug Development Rare Disease Regulatory
Events September 7, 2022
MDIC Annual Patient Forum 2022
We are pleased to share that we will be joining as speakers MDIC Annual Patient Forum 2022 – a key platform for the discussion of how to transform patient engagement throughout the(...)
Clinical Trials MedTech Patient Engagement
Events August 31, 2022
BIOMEDevice 2022
We are excited to share that we will be joining BIOMEDevice 2022 as speakers! This event will bring engineers, business leaders, disruptive companies, and innovative thinkers from the(...)
Investor Relations Medical Devices MedTech
Multimedia August 29, 2022
Webinar Replay: Clinical Trial Management in MedTech & Working with CROs
As a MedTech company, understanding clinical trial management is critical, and working with CROs is part of the journey. Join the webinar to learn about this crucial topic.
Clinical Trial Management CRO MedTech
Events August 23, 2022
MedtechVision 2022
Join us at the MedtechWomen MedtechVision Conference, where we will be presenting a state of the Medtech Industry Report with an overview of the innovation and advancement and much more.
Diagnotics MedTech Patient Centricity
Publications August 4, 2022
White Paper: New European Health Technology Assessment Regulation
In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.
MedTech Regulatory
Publications July 15, 2022
How to leverage registry-based studies to generate high-quality Real-World Evidence
The use of Real-World Evidence (RWE) in regulatory decision making will support the development and application of better medicines.
Real-World Evidence Registry-based studies Regulatory RWE
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.