INSIGHT

Why securing the Class I position for the first product matters

The most important regulatory decision is not always how broad a product can become. Sometimes it is how narrow the first product should be.

For CleverSkin24, securing the Class I position for the current first-aid configuration gives the programme a clearer starting point. It aligns intended use, claims discipline, evidence planning and the first commercial route.

Classification does not remove the remaining work. It does something more useful: it makes the next work easier to sequence.