After an implementation period of four years, the European Regulation (EU) 2017/745 Medical Devices Regulation (MDR) will come into force on May 26, 2021. This regulation has consequences for manufacturers of medical devices and orthopedic shoe manufacturing companies, because they have to comply with stricter safety and quality requirements.
In order to unburden you in the field of leather purchasing, Maasleder has been working for some time to prepare both the organization and materials for additional requirements set by MDR. As proof, we make the following documents available:
• Declarations of conformity to MDR, REACH and Chrome/Metal-free.
• Extensive product data sheets of all leathers in collection for orthopedic shoemaking.
You can conveniently request these documents using the form below.
Requirements on traceability throughout the supply chain is one of the changes that MDR entails. From March 2021 we will therefore print the batch numbers of the items delivered on our packing slips.
You can also trust that Maasleder:
• Has quality management based system on the principles of ISO 13485;
• Has the highest quality standards;
• Has the ERP system UNIT4 Multivers Extended, which guarantees traceability from tannery to delivery;
• Meets additional criteria for products that come into direct contact with the skin;
• Have its materials tested at accredited laboratories on chemical and properties.
Do you have questions about MDR or about the way in which Maasleder implements this legislation? Please do not hesitate to contact us! We are happy to answer questions or to think constructively about your own MDR compliance.