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

News February 7, 2023
The 2023 MedTech Contract Manufacturing Report is released in the U.S.
Alira Health, a global healthcare advisory, clinical research and technology company, announced today the release of the 2023 U.S. MedTech Contract Manufacturing Report in collaboration(...)
MedTech
Publications February 7, 2023
The 2023 U.S. Medtech Contract Manufacturing Report
Read this report to discover the trends in the world of medical device CDMOs and their meaning for the industry.
MedTech
Publications February 2, 2023
Outlook 2023: Firms Prepare For ‘World Where Health Care Has No Limits’
In the latest publication by Medtech Insights by Pharma Intelligence, executives at top device companies and other stakeholders share their expectations.
MedTech Pharma
News January 31, 2023
The Playbook for Patient Engagement in MedTech in the U.S. is Launched
The MedTech Patient Engagement Think Tank announced today the launch of the Playbook for Patient Engagement in MedTech in the U.S.
MedTech Patient Engagement
Publications January 31, 2023
A Playbook for Patient Engagement in MedTech in the U.S.
“A Playbook for Patient Engagement in MedTech in the U.S.” is a result of amalgamating ideas, research, findings, and forecasts from industry subject matter experts that together(...)
MedTech Patient Engagement
Publications January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Medical Devices MedTech Regulatory
Publications January 19, 2023
What’s Next for Diabetes: Patient Engagement, Personalization, and Usable Technology
Alira Health partnered with the ADA to support this conversation and explore the most important topics emerging from patients, physicians, specialists, and patient advocates including(...)
Clinical Trials Diabetes MedTech Patient Engagement
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.