The regulation for medical devices will soon change. That has consequences for personal lube. What are these changes, and how will it affect you?
Medical device or cosmetic?
At this moment, personal lube is being placed to market as a cosmetic product. As of May 2020, these products wil have to be classified as a medical device class IIa. Marketplaces, such as Amazon, e-Bay and Bol.com will no longer sell personal lube that does not adhere to the regulation.
The European Parliament has passed regulation that forces manufacturers of personal lube, to comply to the rules for class IIa medical devices. They have until May 2020 to get a CE-mark for their products.
Now, personal lube is seen as a medical device class I or as a cosmetic product. After May 2020, these products cannot be sold, not even if they are still on stock. Manufacturers, but also suppliers of private labels, have to comply to stringent rules.
What will change?
The changes mostly affect companies, but the goal is to make personal lube safer for the end consumer. Companies that make these products, will have to qualify these products as medical device according to an assessment procedure. Also, they will have to implement certain quality systems (EN ISO 13485:2016). Where there used to be only guidelines, now these companies will have to comply to stringent legislation.
Medical devices are categorized into 4 classes. Class I are medical devices that don’t get into direct contact with the human body, or only get into contact with an undamaged skin for a short period. Class IIa medical devices are products that come in direct contact with a natural body orifice (opening) or damaged skin; Class IIb and Class III are high-risk products such as implants. Personal lubricants are, however, Class IIa medical devices due to their direct contact with a body orifice (vagina, anus) or mucus membrane for a period of continuous contact.
Companies that bring those products to market, have to get a specific assessment in order to get a CE-marking on their packages. For Class I products, manufacturers can apply self assessment. They must register their product at the proper authorities, that can judge of conditions have been met. For Class IIa devices there is a more stringent procedure. Manufacturers have to implement specific quality systems. The ingredients that are used must comply to specific European requirements. The manufacturer must also be able to provide scientific documentation and their products must be labeled in a specific way. Manufacturers will be audited by the authorities, and they will check on the spot if the manufacturer complies to the regulations. The goal is to increase the safety and quality of these products. This might also make an end to the discussion on the safety of glycerine in personal waterbased lube, because manufacturers will need scientific proof in their technical documentation.
How do you know if you are dealing with a Class IIa medical device?
An approved product will have the letters CE on the package, together with a number that identifies the authority of where the product has been registered. Personal lube with a Class I marking does have the letters CE, nut without the accompanying number. If a product is being marked as a cosmetic product, the package will have no CE marking. As of May 2020, only personal lubes with a Class IIa CE marking are allowed on the European market.
If such a CE marking is incorrectly or wrongfully applied, or if the product is not classified as it should be, the product will be removed from the market and the manufacturer will be posed with a penalty.