Medical Device Grouping Under MDR 2017: Can Multiple Medical Device Models Be Covered Under One Licence Application?

Yes. Under the Medical Devices Rules, 2017 (MDR 2017), multiple medical device models may be grouped into a single licence application when they satisfy the applicable CDSCO medical device grouping guidelines.

This provision is based on Rule 5 of the Medical Devices Rules, 2017, which allows applicants to group medical devices in accordance with guidelines issued by the Ministry of Health and Family Welfare. The Grouping Guidelines for Medical Devices Applications, issued by the Government of India in March 2018, set out the conditions under which devices can be grouped.

The important point for manufacturers and importers is that different models, sizes, configurations or features cannot automatically be included in the same grouping. The models must satisfy the specific criteria applicable to the proposed grouping category.

What Is Medical Device Grouping Under MDR 2017?

Medical device grouping under MDR 2017 is a mechanism that allows eligible medical devices to be submitted as part of a single licence application.

The CDSCO guideline states that an applicant may group medical devices having the same or similar intended uses or commonality of technology. The purpose of grouping is the submission of a single application for a licence to import or manufacture the medical devices.

Rule 5 of the Medical Devices Rules, 2017 expressly provides for grouping of medical devices for import, manufacture for sale or distribution, and sale/stock/exhibition/offer for sale or distribution, in accordance with the applicable guidelines.

The recognised grouping categories include:

• Single

• Family

• System

• Group

• In-vitro diagnostic (IVD) Test Kit

• IVD Cluster

The appropriate category depends on the characteristics and intended use of the devices.

Can Multiple Medical Device Models Be Grouped as a Family?

Yes. The Family category is the most relevant grouping route when multiple medical device models have permissible variations.

According to the CDSCO Grouping Guidelines, a medical device Family consists of medical devices where each device:

1. Is from the same licence holder;

2. Has the same risk classification;

3. Has a common intended use;

4. Has the same design and manufacturing process; and

5. Has variations that fall within the scope of permissible variants.

Therefore, different models can potentially be included in one medical device Family even where they differ in certain characteristics, provided those differences remain within the permissible limits prescribed by the guideline.

What Are Permissible Variants Under CDSCO Grouping Guidelines?

The CDSCO guideline states that characteristics may be treated as permissible variants where:

• The physical design and material of construction are the same or very similar;

• The manufacturing processes, including sterilisation, are the same or very similar;

• The intended purpose is the same; and

• The risk profile remains the same after considering these factors.

This is important because simply having the same product name or a similar commercial purpose is not sufficient for Family grouping.

Example: Different Sizes and Colours

The official CDSCO guideline gives condoms differing in colour, size and texture as an example of devices that can be licensed as a Family when they are manufactured using the same material and manufacturing process and have a common intended purpose.

This demonstrates that variation in size or certain physical characteristics does not automatically prevent Family grouping.

Example: Additional Features

The guideline also states that a spherical contact lens with an additional UV-protection feature may be included in a Family where the additional feature does not affect the basic design or manufacturing of the lens.

Therefore, an additional feature does not necessarily require a separate grouping if the applicable Family criteria continue to be satisfied.

When Can Medical Devices Not Be Grouped as a Family?

Grouping is not available merely because devices belong to the same broad product category.

The CDSCO guideline specifically distinguishes between toric and spherical contact lenses. These products have different intended purposes and performances and are designed and manufactured differently. Accordingly, they should not be considered members of the same Family.

This illustrates a key principle of CDSCO medical device grouping:

Significant differences in intended purpose, design, manufacturing process or risk profile can prevent multiple models from being grouped as a Family.

Medical Device System Grouping

A System is another grouping category under the CDSCO guidelines.

A medical device System consists of devices that:

• Are from the same licence holder;

• Are intended to be used in combination to achieve a common intended purpose;

• Are compatible when used as a System; and

• Are sold under a single proprietary System name.

The CDSCO guideline provides a hip replacement system as an example, comprising femoral and acetabular components. The sizes of the components may vary while the components are used together to achieve the common intended purpose of total hip replacement.

A glucose monitoring System comprising a glucose meter, test strips, control solutions and linearity solutions is another example provided by the guideline.

Importantly, where several Systems themselves satisfy the applicable Family conditions, the guideline states that they may be licensed as a Family.

Medical Device Group Category

A medical device Group consists of two or more medical devices supplied in a single package by the same licence holder and sold under a single proprietary Group name with a common intended purpose.

The devices within the Group may have different proprietary names and intended purposes. The Group may also vary in the number and combination of products included, provided the Group continues to meet the applicable requirements.

The CDSCO guideline uses a first-aid kit containing devices such as bandages, gauzes, drapes and thermometers as an illustration of a medical device Group.

However, a medical device that forms part of a Group cannot simply be treated as covered by the Group if it is subsequently sold separately. The CDSCO guideline states that devices forming part of a Group must be licensed separately before being sold separately as individual medical devices.

IVD Test Kit and IVD Cluster Grouping

The CDSCO framework also provides specific grouping categories for in-vitro diagnostic medical devices (IVDs).

An IVD Test Kit consists of reagents or articles from the same licence holder that are intended to be used together for a specific intended purpose, sold under a single proprietary Test Kit name and compatible when used as a Test Kit.

An IVD Cluster consists of IVD reagents or articles that are:

• From the same licence holder;

• Based on a common methodology;

• Sold under a single proprietary name; and

• Compatible when used as a Test Kit.

Does Grouping Change the Risk Classification of a Medical Device?

No. Grouping should not be understood as a mechanism for changing the applicable risk classification of an individual medical device.

The MDR 2017 framework classifies medical devices into Class A, B, C and D according to the applicable classification provisions. The Family grouping criteria themselves require devices within a Family to have the same risk classification class.

Accordingly, applicants should determine the appropriate classification of the relevant devices and then assess whether they satisfy the applicable grouping requirements.

What Should Manufacturers Check Before Applying for Grouping?

Before submitting a CDSCO medical device licence application, manufacturers and importers should assess every proposed model against the applicable grouping criteria.

For a proposed Family, the key questions include:

• Is the licence holder the same?

• Are all devices in the same risk classification class?

• Do they have the same common intended use?

• Do they have the same design and manufacturing process?

• Are differences between models within the permitted permissible variants?

• Are the physical design and materials the same or very similar?

• Are the manufacturing and sterilisation processes the same or very similar?

• Does the overall risk profile remain the same?

If the answer to these questions is no, the applicant should carefully assess whether another grouping category is applicable or whether the devices need to be licensed separately.

Benefits of Medical Device Grouping

Where the applicable criteria are satisfied, medical device grouping can make the regulatory submission process more efficient by allowing eligible devices to be included in a single licence application.

However, grouping should not be viewed as a way to combine unrelated products merely to reduce the number of regulatory submissions. The devices must meet the relevant criteria established by the CDSCO Grouping Guidelines.

The official guideline expressly states that medical devices that cannot be assigned to an applicable grouping category must be licensed separately.

Key Takeaway

Yes, multiple medical device models can be covered under the same grouping category under MDR 2017, provided they satisfy the applicable CDSCO grouping criteria.

For products that differ only in permissible ways—such as certain variations in size, colour, texture or features—the Family category may be appropriate where the devices have the same licence holder, risk classification, common intended use, design and manufacturing process, and the variations remain within the permissible-variant criteria.

Other arrangements may qualify as a System, Group, IVD Test Kit or IVD Cluster, depending on the nature of the products and how they are supplied and intended to be used.

The governing framework is Rule 5 of the Medical Devices Rules, 2017, together with the Grouping Guidelines for Medical Devices Applications issued by the Government of India in March 2018. CDSCO's current Medical Device & Diagnostics resources also continue to list grouping guidance and FAQs for medical devices.

Manufacturers and importers should therefore map each model against the applicable CDSCO medical device grouping criteria before filing an application rather than assuming that all variants of a product can automatically be included under one licence.

Frequently Asked Questions

Can different models of the same medical device be included in one CDSCO application?

Yes, potentially. Multiple models can be included where they satisfy the requirements of an applicable grouping category, particularly the Family criteria.

Can medical devices with different sizes be grouped?

Yes, size differences may be permissible where the devices otherwise satisfy the Family criteria. The CDSCO guideline expressly provides condoms differing in size as an example.

Can medical devices with different designs be grouped?

Not automatically. The Family criteria require the devices to have the same design and manufacturing process, while permissible variants must have the same or very similar physical design and materials.

Can different risk classes be included in one Family?

No. The CDSCO Family definition requires each device to have the same risk classification class.

Can a device in a Group later be sold separately?

If a device forming part of a Group is to be sold separately as an individual medical device, the CDSCO guideline states that it must be licensed separately.

Where can I find the CDSCO grouping guidance?

CDSCO publishes its medical-device rules and grouping guidance through its official Medical Device & Diagnostics resources. The March 2018 Grouping Guidelines for Medical Devices Applications were issued pursuant to Rule 5 of MDR 2017.

Regulatory disclaimer: This article is for general regulatory information and should not be treated as legal or regulatory advice for a specific product. The applicable CDSCO/MoHFW rules, notifications, guidance and licensing requirements should be reviewed for the particular device and application.

Last Updated : 20 Aug 2026