The Ethiopian Food and Drug Authority (EFDA), the country’s regulating agency responsible for medical devices, has published a guidance document dedicated to medical device bundling in the context of marketing authorization application.
Regulatory Background
To be marketed in Ethiopia, medical devices must have the appropriate authorization granted by the EFDA after assessment of safety and performance. The extent to which the authority will investigate a medical device in question depends on its type, intended purpose, and risks associated thereto.
Depending on the construction and intended purpose, medical devices could be placed on the market either as separate products or together being connected in a set if it is reasonably necessary for them to perform their function. In such a case, the approach to be applied by the authority will also be different – in order to simplify the procedures and reduce the unneeded regulatory burden, the authority will assess both products together in their combination. The building criteria are intended to determine whether the medical devices subject to review could be combined in a single application for marketing authorization in order to reduce the time necessary to review the application and ensure timely access to novel products in the market.
The present document describes the bundling criteria and provides recommendations and clarifications regarding how they should be applied. The authority also mentions that the provisions of this guidance are not binding, and in the case of any contradictions with the provisions of the current legislation, the latter should prevail.
The scope of the document covers any and all medical devices subject to premarket authorization, including in vitro diagnostic ones, for which the manufacturer intends to submit an application for marketing authorization of several devices. The grouping principles described in the document could be applied to medical devices of all types.
First, the document provides the definitions of the most important terms used in the context of medical device bundling and grouping, including the following:
- Bundling or grouping stands for the inclusion of multiple medical devices with the same intended purpose in a single premarket submission for the purposes of facilitating review and reasonably reducing the user fee payment.
- Intended purpose (use) – the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
- Proprietary (generic) name – a unique name given by the product owner to identify a medical device as a whole product, also known as the trade name or brand name.
Besides those listed above, the document also provides the definitions of such terms as “in vitro diagnostic medical device,” “legal manufacturer,” and “surgical instruments.”
Bundling/Grouping Principles
According to the document, the bundling should be reasonably cost-effective and scientifically justified from the applicant’s standpoint and simple and cost-effective to review for the EFDA. When determining the eligibility of medical devices for bundling, the applicant shall consider the specific aspects of the medical devices in question. It is also important to mention that supporting data submitted by the manufacturer together with the application for marketing authorization should be similar as well – the same reviewer should perform the review.
The EFDA outlines the following main bundling principles:
- The devices should have one generic name,
- The devices should have one trade name (if any),
- The devices should be from one legal manufacturer or product owner,
- The devices should have one intended purpose.
The authority additionally emphasizes that each device in a group should comply with any and all regulatory requirements in terms of safety and effectiveness.
Bundling Criteria
As mentioned, responsible parties may group several medical devices within a single application for marketing authorization, provided that they have the same or similar intended use, are based on the same technology or are manufactured by the same medical device manufacturer. In such a case, grouping could facilitate the review and reduce the time necessary for the authority to review the application. It also allows the applicant to significantly reduce the expenses associated with placing medical devices on the market. Thus, depending on the number of medical devices included, the applications for marketing authorization could fall into one of the following categories:
- Single,
- Family (more than one medical device type & differ in shape only),
- System (more than one constituent component),
- Set (more than one medical device type assembled together and supplied in a set),
- IVD test kits (a device that consists of reagents or articles),
- IVD Cluster (reagents or articles of common test methodology).
An application for single medical device marketing authorization should be submitted by the applicant if any of the categories above could not be applied due to the specific features of a medical device in question. This approach should also be applied if a medical device is initially intended to be sold and used separately. If a medical device has been placed on the market as a part of a group, a separate application could be required in order for the device to be allowed to be sold separately. In general, a single application could be submitted in the case of several similar medical devices being sold in one package (e.g., gloves).
Stand-alone medical software should also be subject to premarket review as a single medical device.
A medical device family is a group of medical devices in which:
- All products are made by the same manufacturer,
- All the devices have the same class under the risk-based classification,
- All the devices are intended for the same purpose, have a common design and manufacturing process,
- All variations to the medical devices are within the scope of permissible ones.
A medical device system is a group of products combined in order to be used for a common intended purpose. To meet the eligibility criteria, a medical device system shall:
- Be manufactured by the same entity,
- Be placed on the market under a single name,
- Consist of medical devices compatible to be used together,
- Contain instructions for use describing the way a system should be used.
If the same component constitutes a part of several groups, it should be included in marketing authorization applications for each group.
Such an approach is widely used for in vitro diagnostic medical device systems comprised of test kits and instruments.
A medical device system could contain not only separate medical devices but also accessories.
A medical device set stands for a collection of two or more medical devices, assembled together and supplied in a single package by the same legal manufacturer/license holder.
In summary, the present EFDA guidance describes in detail how medical devices could be grouped for the purpose of applying for marketing authorization. In particular, the document outlines the categories and criteria to be applied depending on the type of medical devices, their intended purpose, and features.
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