Classification of medical devices

It is widely accepted that there should be a method to separate medical devices into a small number of groups, or classes, and subsequently apply different conformity assessment techniques to each class.

The global adoption of a rules-based classification procedure would offer significant benefits to manufacturers, users, patients, and regulatory authorities (RA) and support global convergence of regulatory systems.

Manufacturers of medical devices are subject to regulatory controls overseen by national regulatory authorities (RA’s). The RA specifies procedures to be followed by manufacturers during the design, manufacture, and marketing of each device, and describes the manner in which a manufacturer should demonstrate conformity to such procedures.

The determination of class is based on rules derived from the potential of a medical device to cause harm to a patient or user (i.e. the hazard it presents) and thereby on its intended use and the technology/ies it utilises.

Global Harmonization Task Force (GHTF) has prepared guidance document with set of rules which assist a manufacturer to allocate its medical device to an appropriate class using a set of classification rules; and allow RAs to pronounce upon matters of interpretation for a particular medical device, when required so to do.

http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf

General classification system for medical devices as per Global Harmonization Task Force (GHTF):

Class A: Low hazard (ex: Bandages/tongue depressors)
Class B: Low moderate hazard (ex: hypodermic needles/suction equipment)
Class C: Moderate to high hazard (ex: Lung ventilator / bone fixation plate)
Class D: High Hazard (Heart valves / implantable defibrillator)

The actual classification of each device depends on the claims made by the manufacturer for its intended use and the technology/ies it utilises.

MEDICAL DEVICE REGULATORY CLASSIFICATION IN THE U.S.:

In the United States, medical devices are regulated by the Food & Drug Administration, or FDA. The specific branch within the FDA is the Center for Devices & Radiological Health (CDRH).

The mission of CDRH is to protect and promote public health. In the U.S., medical devices are either Class I, Class II, or Class III. The FDA CDRH classification is based primarily on risk the medical device poses.

Classification is directly related to intended use and indications for use.

Intended Use is the general purpose of the medical device or its function (what you “claim” the medical device does).
Indications for Use describe the disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.

FDA defines three regulatory controls for each medical device class:

Class I medical device (low to moderate risk): General Controls
Class II medical device (moderate to high risk): General Controls and Special Controls
Class III medical device (high risk): General Controls and Premarket Approval (PMA)

MEDICAL DEVICE CLASSIFICATION IN EUROPE

The regulations for a medical device in European Union (EU) are established through the Medical Device Directives by the European Commission (EC). The path to market in Europe is to obtain a CE marking.

The European Union’s medical device regulation (EU MDR) includes the necessary information to determine device class. EU MDR 2017/745 amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. EU MDR become the mandatory regulation for medical devices from May 2020.

The European Union has 4 main categories for Medical Devices classification:

Class I
Class IIa
Class IIb
Class III

This goes from the products with low risk (Class I) to the products with high risk (Class III).

Classification is directly related to device use:

Non-Invasive
- Any device which does not penetrate the body through an orifice or the surface of the body. These devices are typically Class I; however, certain rules and exceptions apply that could make them Class II or higher.
Invasive
- Any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
Active
- Any device whose operation depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy.

For each of the broad categories, there are certain rules which apply, outlined in Annex VIII of the new medical device regulation. These categories coupled with the duration for use make determining classification fairly straightforward.

For example, a device in continuous use for under 60 minutes is considered transient duration, 60 minutes to 30 days is considered short-term, and over 30 days is considered long-term.

MEDICAL DEVICE CLASSIFICATION IN CANADA

The medical devices regulations in Canada are established by the Government of Canada and regulated by Health Canada.

Health Canada defines four groups of non-in vitro diagnostic medical devices:

Invasive Devices
Non-Invasive Devices
Active Devices
Special Rules

For each of the broad categories, there are a set of rules which apply. These rules are what manufacturers should follow in order to determine the risk classification of their device.

There are four levels of medical device classifications in Canada:

Class I
Class II
Class III
Class IV

Japan Medical Device Classification

Under Japan PMDA regulations, a medical device can be classified as a General Medical Device (Class I), Controlled Medical Device (Class II), or a Specially Controlled Device (Class III and Class IV), depending on the risk level.

Australia (TGA) Medical device classification

Referance:

Classification of medical devices

Ramya

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