When we’re using a product, its regulatory status is not likely to be at the forefront of our minds. But if we did stop to question it, the answer may surprise us.
Take the toothbrush. We might be inclined to think that its connection with healthy teeth would make it a medical device. In the EU this is not the case. In fact, it’s regulated as a cosmetic.
Dermal fillers are a different matter. When used for aesthetic purposes they are not, in fact, cosmetics, but are medical devices. Not because they serve a medical purpose, but because the risks linked with their use necessitate the regulatory stringency required for high-risk, implantable medical devices.
The Dutch Healthcare and Youth Inspectorate (IGJ) recently published a cautionary message on dermal fillers from illegal sources administered by unqualified professionals. These fillers may not have the safety profile required by EU law, something not necessarily obvious to the consumer.
Get the regulatory status of a product wrong and consumers can be put at risk. This is ultimately the responsibility of the manufacturer, but caution along the entire pathway to commercialisation and end use is prudent so that consumers can make informed choices, trusting as they should be able to in the safety of the product.
Our regulatory affairs consultants help manufacturers define the correct regulatory status of their product. Need support? Contact Starodub for more information at www.starodub.nl.
