Adhesives for Hygiene Medical Devices

Few products come as close to consumers on a regular basis as personal hygiene products. Safety and quality are critical factors for consumers, and it drives buying behavior. Several countries have begun implementing regulations to assure a high-level of protection. The Medical Device Regulation is designed to set quality and safety standards for these devices to address common safety concerns with the goal is to protect consumers.

As the population demographics changing and the population aging, certain health conditions are becoming more prevalent. Approximately 450 million people globally are affected by incontinence, which often impacts their quality of life. The advances in adult incontinence products enables people with health issues to live independently, for longer. Personal hygiene manufacturers are now medical device manufacturers, and they need solutions to support both the transition, and the growing demand for adult diapers. 

Understanding the Medical Device Regulation for Adult Incontinence Products

The definition of medical devices is diverse. Defined as an instrument, apparatus or piece of software intended for human use with the purpose of diagnosis, monitoring, prevention, or treatment of a medical impediment. Manufacturers need to understand where their products fall to assure the adhesives comply with the correct regulatory standards

To protect consumers and assure the optimum safety of incontinence products, the European Union's new Medical Device Regulation 2017/745 was enacted in May 2021 and replaced the Medical Device Directive (MDD). The regulation covers the clinical testing and sale of medical devices for use on humans. The MDR states adult incontinence products as Class I medical devices.  Existing adult incontinence products already licensed remain valid until May 2024. All new devices introduced to the market must conform with the MDR.

The result: a tailored portfolio of adhesives, that meet the requirements of MDR, designed for hygiene product manufacturers

Delivering Adhesives for MDR compliant Adult Incontinence Products

Henkel developed a portfolio of hot melt adhesives that deliver reliability and transparency needed for Class I medical devices. These TECHNOMELT^® products play a key role in the performance and safety of adult incontinence products. Henkel’s solutions deliver:

• Our Best in Class Quality: Adhesives designed for hygiene manufacturing, excellent processability and produced with the highest quality standards
• Expertise At Your Fingertips: dedicated program team with broad technical capabilities that include PSRA, toxicology experts, supply chain and operations personnel with practical expertise during the MDR transition
• Transparency & Reliability: Conscious selection of raw materials, suppliers and production facilities to ensure highest standards of safety and formula control

Henkel’s adult incontinence hot melt adhesives portfolio, the MED range, offers excellent quality, performance and processability, while addressing the regulatory requirements. It assures stability over time, long shelf life and low odor – fulfilling the demands and requirements of the medical industry. These products meet the highest standards of purity as dictated by ISO10993-5 and ISO10993-10 guidelines.

Supporting Manufacturers of Class 1 Medical Devices

Hot melt adhesives are fundamental to the performance of adult incontinence products. Henkel supports personal hygiene product manufacturers with:

• No hazardous substances: strict internal selection of raw materials, suppliers, and support manufacturers with standardized and comprehensive conformity declarations
• Bio-compatibility: hot melt adhesives passed ISO 10993-5 cytotoxicity testing
• Change Management: frozen formulas, leading plant systems, and a robust quality system address regulatory compliance
• Quality Management System: medical device adhesives manufactured in ISO 9001 approved plants (instead of ISO 1345)