The Medical Devices Rules (MDR), 2017, notified by the Government of India, established a comprehensive regulatory framework for the manufacture, import, sale, and distribution of medical devices. One of its key provisions is the grouping of medical devices, which allows manufacturers to obtain a single license for related products instead of applying separately for each device. This approach simplifies regulatory submissions, reduces administrative burden, and supports efficient product lifecycle management while ensuring compliance with the standards prescribed by the Central Drugs Standard Control Organization (CDSCO).
For manufacturers, importers, authorized agents, and regulatory professionals, understanding the grouping criteria under MDR 2017 is essential. Proper grouping not only streamlines licensing but also minimizes delays caused by incorrect classification or incomplete documentation.
Medical device grouping is the process of combining multiple medical devices under a single regulatory application when they meet specific criteria defined under MDR 2017. Instead of submitting separate applications for every product variant, manufacturers can group eligible devices based on their intended purpose, design, manufacturing process, technology, and risk classification.
This regulatory concept aligns with international practices and offers significant advantages, including:
A Single Medical Device is an individual device with one intended purpose and a unique design. Variations such as size or capacity are acceptable provided they do not alter the intended use or fundamental design.
Examples:
These products perform the same medical function and are therefore treated as one medical device.
A Family of Medical Devices consists of products that:
Since these differences do not impact safety or performance, the devices may be grouped under one application.
Example: Orthopedic bone screws manufactured in different lengths and diameters.
A Medical Device System includes multiple devices designed to work together to achieve a specific medical purpose. These devices:
Example: An ultrasound imaging system comprising an ultrasound console, monitor, imaging probes, and power accessories.
A Procedure Pack is a collection of two or more medical devices packaged together for a specific medical procedure. Unlike a system, the devices do not necessarily function together mechanically but are assembled for clinical convenience.
Examples:
All components included in the pack must be identified during registration.
A Medical Device Group may be formed when products:
This grouping is particularly useful for products with comparable technology but marketed under different product names.
In Vitro Diagnostic (IVD) medical devices follow separate grouping principles because they primarily consist of reagents, controls, calibrators, instruments, and consumables used for diagnostic testing.
A Single IVD Medical Device performs one specific diagnostic test using a unique testing principle.
Examples:
IVD products may be grouped as a family when they:
Example: Blood glucose reagents available in packs of 50, 100, and 200 tests.
An IVD Test Kit consists of reagents, controls, calibrators, and accessories packaged together to perform a specific diagnostic test.
Examples:
Since all components work together to generate the diagnostic result, they are registered as one test kit.
An IVD System includes instruments and associated reagents intended to function together for diagnostic testing.
A typical system may include:
Each component contributes to the overall testing process and is evaluated collectively.
An IVD Cluster consists of multiple IVD products intended to be used together for related diagnostic purposes. Unlike a test kit, each product performs a separate test, but together they provide sufficient clinical information for diagnosing a particular disease or analyte.
This approach supports comprehensive diagnostic panels while simplifying regulatory submissions.
Medical devices are classified into four risk categories based on intended use and potential risk to patients.
|
Risk Class |
Risk Level |
|
Class A |
Low Risk |
|
Class B |
Low-Moderate Risk |
|
Class C |
Moderate-High Risk |
|
Class D |
High Risk |
Risk classification is one of the primary factors considered when determining whether products can be grouped under a single regulatory application.
Grouping offers several regulatory and commercial advantages, including:
These benefits enable manufacturers to optimize regulatory resources while maintaining compliance with MDR 2017.
The Medical Devices Rules (MDR), 2017 provide a structured framework for grouping medical devices and IVD medical devices in India. Categories such as Single Medical Devices, Medical Device Families, Systems, Procedure Packs, Medical Device Groups, Single IVD Devices, IVD Families, IVD Test Kits, IVD Systems, and IVD Clusters enable manufacturers to streamline regulatory submissions while ensuring compliance with CDSCO requirements.
Last Updated : 15 Jul 2026
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