The scope of the guidance covers, inter alia, the aspects related to bundling medical devices when applying for marketing approval. In accordance with the applicable regulatory requirements, some medical devices can be grouped (bundled) in one submission, while others should be submitted separately. The document describes in detail the criteria to be applied when determining whether the medical devices in question are eligible for binding. In general, all medical devices could be divided into the following groups:
- Single medical devices;
- Medical devices family;
- Medical devices system(s);
- Medical devices procedure pack;
- IVD (In-Vitro Diagnostic).
The document further outlines specific criteria to be considered when determining eligibility for bundling. According to the guidance, these criteria include the following ones:
- Several medical devices being manufactured by the same legal manufacturer;
- Intended use (including the use in combination to complete a common intended purpose);
- Risk classification;
- Brand name;
Single Medical Devices
First of all, the document describes the approach to be applied with respect to single medical devices – the ones that could have differences in color, size range, etc. According to the document, medical devices that have more than one model may be bundled/grouped within one application only if they have:
- Same legal manufacturer;
- Same intended use;
- Same risk class; and
- Same brand name.
Medical Devices Family
The guidance further describes the approach to be followed in the case of a group of single medical devices having the same manufacturer, intended use and risk classification, but with differences related to characteristics and features. This includes the changes related to materials used, patient groups, energy source, additional function. According to the guidance, such products could be bundled in case they have:
- Same legal manufacturer;
- Same intended use;
- Same risk class.
Medical Devices System(s)
As defined in the guidance, a medical device system stands for a device comprised of a number of single medical devices, which can be combined or operated in combination to achieve a common intended use/purpose. In order to be eligible for bundling within one application, medical devices with different intended use should be manufactured by the same manufacturer, be intended for use together (in combination) to achieve the intended purpose, be compatible with each other, and also to be supplied under the common name, accompanied with the instructions for use for each of the components.
Medical Devices Procedure Pack
According to the guidance, medical devices procedure pack stands for a collection of two or more medical devices, assembled together to perform a certain procedure as one package by a manufacturer. The authority additionally emphasizes that in order to be eligible for bundling, medical device procedure packs should have conformity assessment under article 12 of EU MDD 93/42/EEC. Other applicable criteria include the following ones:
- Same manufacturer;
- Common intended use;
- Specialty as the main factor for bundling.
It is also stated that a single application cannot exceed 50 items.
The document also describes the requirements applicable in the case of in vitro diagnostic (IVD) medical devices. According to the guidance, in order to meet the applicable eligibility criteria, such devices should have the same risk classification, intended use, and be subject to the same original approval.
The document contains flowcharts illustrating the way the approach described in the guidance should be applied. The flowchart outlines the criteria to be applied when determining the eligibility of different product types.
Terms and Definitions
The guidance also provides definitions of the most important terms and concepts used in the context of the registration of medical devices in order to ensure their correct interpretation. The terms defined in the guidance include, inter alia, the following ones:
- Quality Assurance Certificate Verification stands for checking the validity of the quality assurance certificate by contracting the notifying body either by sending an email (6 month validity) or online through the website of the notifying body.
- Audit Report is defined as report issued from the notifying body to ensure the manufacturer’s process and documentation in addition to the corrective action taken in case of non-compliance is as per international standards.
- Authorized Representative is a firm registered by NHRA, authorized by the manufacturer through an official document; declaring them as their representing entity in the kingdom of Bahrain.
In summary, the present NHRA guidance describes the approach to be applied when determining the eligibility for bundling in the context of applying for marketing approval. The document outlines the applicable criteria and highlights the key points to be taken into consideration.
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