The Importance of intended use and marketing claims as part of the qualification and classification of a medical device

When looking to design and develop a new medical device, or in the case of changes or regulation like we have seen from EU MDD to EU MDR one of most important planning steps in the journey to commercialization of the medical device is qualification and classification.

Qualification is assessing whether a product is a medical device, and must follow the applicable regulations, or another type of product which would need to meet different regulations.

Classification is assessing what specific regulatory rules and risk classification the product needs to meet.

As part of qualification and classification, the product’s intended use and marketing claims are of utmost importance to define – as changes to these can have a big impact on both qualification and classification of the product.

As an example of qualification, many products contain the chemical Chlorhexidine as an antimicrobial agent. Several mouthwashes contain Chlorhexidine, and depending on the product claim it can be qualified as either;

1.     A cosmetic product, if there are no medical claims made about the antimicrobial effect.

2.     A drug, if provided as a mouthwash with a medical claim on helping treat gum disease through the antimicrobial effect.

3.     A medical device, if provided with other ingredients intended to mechanically help to treat gum disease, with or without a claim on the antimicrobial effect (combination medical device and drug product).

Similarly classification can often be very geared around the specific intended use and claims made. For example a scalpel can be used a craft knife, which would be a general consumer product. The same scalpel can be used as a medical device for cutting into the body, and depending on the claim can fall into several risk classifications under EU MDR 2017/745, from very high risk to very low risk;

–       Class I reusable, as scalpel intended for cutting into the skin.

–       Class IIA, as a single use scalpel intended for cutting into the skin.

–       Class III, as a single use scalpel intended specifically for cutting brain tissue.

In all the classification examples above, we are considering the same physical scalpel – the only change is to the intended use and marketing claims being made about the product.

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