How is Your Device Used?
Intended Use versus Indication for use – what’s the difference?
Since these terms entered the regulatory landscape, the difference between “intended use/purpose” and “indication for use” has frequently given our clients cause for consternation. Although the terminology of both may seem similar at first sight, the terms are far from interchangeable.
Intended use refers specifically to the claim reflected by a device’s labelling, which states what the device is actually meant to do. Whereas the indication for use describes the situations in which someone would use the device. Under the MDR, it is especially important to have a well-defined intended use, as you also need to justify and list all the clinical benefits, which will stem from this initial labelling statement. So, clarity is key.
OK – practically speaking then, how do you determine these key terms within your device documentation, to comply with the regulations and maximise the use and sales of your device?
Let’s consider for a moment, that a common bottle is a medical device; the intended use of this bottle is to contain fluid. This could be true for a bottle that contains say, shampoo or drinking water – but the indication for use of the same 2 bottle would be very , because of the nature of its contents. The water bottle’s indication for use would be to contain fluid for consumption and the shampoo bottle to contain chemical fluid for a medical condition. Most importantly though, these statements would then have very different risks and thus would require different labels and warnings, etc.
The same can be true for catheters, scalpels, dressings etc, dependent upon their characteristics. So it’s important to determine the correct statement for your device at the outset, due to the impact which they have on the construction and content of multiple subsequent documents, such as the clinical evaluation, the instructions for use, labelling, and potentially even the promotional or sales materials.
When thinking about your own device’s intended use, it’s also important to take into consideration the information about the intended patient population, the relevant medical conditions, indications and contraindications, as well as the information on the principles of the operation of the device and the mode of action.
It is always best to be clear and unambiguous when fulfilling technical documentation, as precise statements are also easier to justify and support with evidence, particularly when creating the clinical evaluation. If you need to adjust either of these key terms halfway, it can use a lot of time and resource to remediate subsequent documentation too, so getting it right first time is crucial.
If you would like guidance on defining intended use or indication of use for your device, one of IMed’s experts can help. Call us now on 01295 724286 or email Al Mills on firstname.lastname@example.org
RA & Clinical Consultant