With a dedicated product portfolio and expert support, Henkel helps manufacturers fulfill EU Medical Device Regulation certification requirements
The European Union’s MDR (Medical Device Regulation) is ushering in a new era of supply chain transparency and higher standards of safety for products used in the healthcare sector. While welcome, the introduction of MDR presents challenges for hygiene product manufacturers whose products are now classified as medical devices. From end of May 2021, all incontinence products have been classified as “class 1 medical devices”, with products currently on the market requiring recertification by 2024. For many manufacturers, this process may require more stringent quality management and traceability for products and their component materials than previously. Yet, this transition needs not be burdensome: As a leading supplier to the healthcare and hygiene sectors, Henkel is helping its customers ensure their products are ready for MDR. This is particularly important, as adhesives are key components of hygiene products and highly relevant regarding this compliance.