Medzus | MDR 2017 India
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Medical devices and in-vitro diagnostics will be classified into four categories, depending upon the indications for use and risk level of the device.

The new rules establish a risk-based approach, whereby the level of regulation varies considerably depending on the risks and technology associated with the device’s intended use and technological characteristics. Four classes (Class A, B, C, and D) have been established under the new framework, where Class A and B present the least risk and Class C and D devices present higher risk to patients.


For example, an elastic bandage or a mechanical barrier used for compression or for absorption of exudates for wounds that have not breached the dermis and can heal by primary intention would be classified as a Class A device. An example of a Class B medical device is contact lenses whereas a blood bag that does not incorporate a medicinal product would be considered a Class C device. Finally, a transient-use surgically invasive medical device intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring, or correction of a heart defect or central circulatory system condition through direct contact with body parts would be an example of a Class D device.

An example of a Class B medical device is contact lenses whereas a blood bag that does not incorporate a medicinal product would be considered a Class C device.Finally, a transient-use surgically invasive medical device intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring , or correction of a heart defect or central circulatory system condition through direct contact with body parts would be an example of a Class D device.

Clinical investigation framework added.

The Medical Device Rules have added a new regulatory framework for clinical investigations. The government requires that clinical investigations in humans be approved prior to initiation. Further, permission must be obtained to import or manufacture investigational medical devices to conduct clinical investigations.