Key Findings
Henkel Adhesive Technologies has introduced five next-generation Loctite light-cure adhesives: Loctite AA 3914, AA 3915, AA 3917, AA 3937, and AA 3964. These products are specifically formulated to address the regulatory thresholds defined in the Medical Device Regulation (EU MDR 2017/745), specifically Section 10.4.
Technical Details
The new AA-series adhesives are engineered with the following technical specifications and improvements:
- Chemical Composition: Formulations contain less than 0.1% by weight of carcinogenic, mutagenic or toxic for reproduction (CMR) substances, endocrine disruptors (ED), and Trimethylbenzoyl Diphenylphosphine Oxide (TPO).
- Testing Protocols: The products were tested according to Henkel protocols based on ISO 10993.
- Visual Inspection: The grades feature enhanced fluorescence stability both before and after curing to facilitate in-line visual inspection.
- Durability: The adhesives demonstrate improved strength retention in accelerated aging tests, supporting long-term device performance and validation.
Background and Context
The development of these adhesives responds to the EU MDR 2017/745, which places increased emphasis on the restriction of CMR substances and endocrine disruptors. This regulatory environment has forced medical device manufacturers to reassess existing material choices to ensure future compliance. Henkel’s approach focuses on providing validated materials that reduce risk during the product development and manufacturing process.
Significance and Outlook
The launch allows manufacturers to navigate complex regulatory shifts without sacrificing manufacturing efficiency or bonding reliability. Henkel will demonstrate the portfolio at two upcoming industry events: MD&M Midwest in Minneapolis on 28–29 October 2026, and COMPAMED in Düsseldorf on 16–19 November 2026. While the products are designed for these regulatory thresholds, Henkel advises customers to conduct their own suitability testing for specific applications.
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