Did you know that personal lubricants have now been reclassified as medical devices? With stricter regulations coming into effect in 2024, it’s crucial for businesses in the sexual wellness industry to stay informed about these changes. In this article, we’ll summarize what exactly is altering for personal lubricants and their manufacturers, and provide essential information for buyers within the sexual wellness industry.
Personal Lubricants: Now Classified as Medical Devices!
Intriguingly, personal lubricants are no longer considered mere cosmetics but have transitioned into medical devices. Given that they are introduced into the body and often remain there, this reclassification aligns with their usage. The new categorization places personal lubricants alongside high-risk medical devices like defibrillators. Consequently, manufacturers must now adhere to stringent regulations outlined in the European Medical Device Regulation (MDR) to continue selling their products as personal lubricants or creams.
Changes to Personal Lubricant Labels
As of 2024, the criteria for products being marketed as “personal lubricant” have become more stringent. Professionals in the sexual wellness industry must carefully review product labels to ensure compliance with new regulations. Labels on personal lubricants must include the MD (Medical Device) and CE (Conformité Européenne) marks, along with an expiration or use-by date. They should also feature a unique four-digit code, which corresponds to a designated certification entity that has confirmed the product meets the stringent health, safety, and environmental protection benchmarks that come with the CE designation.
Furthermore, buyers should pay attention to the detailed information provided on the label’s backside. The intended use, such as “for daily use“, must be explicitly stated. Class IIb medical devices, including personal lubricants, must also indicate their compatibility with other products, such as condoms. Safety warnings, for instance, “Avoid contact with eyes and irritated skin,” must be prominently displayed. A comprehensive article on how this information should appear on personal lubricant labels can be found online.
Implications for Manufacturers and the Sexual Wellness Industry
This transition poses a significant challenge for manufacturers who have not yet acquired MDR certification. To continue selling their products as “personal lubricants,” these manufacturers must comply with MDR directives, ensuring the safety of their offerings. While the transition period for implementing the new MDR lasts until May 2024, some manufacturers may struggle to meet the requirements in time. As a result, the range of personal lubricants available in the market may change. However, industry leaders like pjur have already obtained certification, guaranteeing their continued production and sale of personal lubricants.
Enhancements in Consumer Safety
As a buyer in the sexual wellness industry, the strict regulations surrounding personal lubricants will undoubtedly benefit you. Whether you choose pjur or other certified manufacturers, you can trust that these products meet the highest safety standards. With meticulous reviews, certified quality, exceptional compatibility, and guaranteed safety, your concerns about the quality of personal lubricants can be alleviated. Embrace worry-free pleasure and revel in the enhancement personal lubricants offer for intimate experiences.
As a business within the sexual wellness industry, it’s vital to stay well-informed about the evolving landscape of personal lubricants. Starting in 2024, personal lubricants will undergo stricter scrutiny and can only be classified as such if they adhere to the rigorous MDR directives for Class IIb medical devices. By ensuring labels display the necessary information and purchasing from certified manufacturers like pjur, buyers can confidently offer their customers the highest quality personal lubricants. Enjoy the benefits personal lubricants bring to your customers’ experiences and embrace the exciting changes in the market!
pjur group Luxembourg S.A. is a certified manufacturer of medical devices. You can find our EU Declaration of Conformity and Certificates here.