Internally and externally approved leather complying with MDR regulation

Our leather is extensively inspected internally and externally in accordance with current European guidelines and our own quality requirements. With Maasleder, you are assured of an honest product, produced taking into consideration matters of current social concern.

To ensure responsible use in medical devices, our leather complies with the principles of the European MDR regulation.

After a four-year implementation period, European Regulation (EU) 2017/745 Medical Devices Regulation (MDR) finally entered into force on 26 May 2021. This regulation affects medical device manufacturers and orthopaedic shoe companies by requiring them to meet stricter safety and quality requirements.

Quality management system for the highest quality leather

Maasleder takes care of all your leather purchasing needs. You can rest assured that Maasleder

  • Has implemented a quality management system based on the principles of ISO 13485;
  • Maintains the highest quality standards;
  • Has the ERP system UNIT4 Multivers Extended, which ensures traceability from tannery to delivery;
  • Meets the additional criteria for products in direct contact with the skin;
  • Has its materials tested at accredited laboratories for both chemical and physical properties.

Requirements for traceability throughout the supply chain are one of the changes MDR has brought about. From March 2021, we therefore print the batch numbers of delivered items on our packing slips.

Any questions? Get in touch

Do you have any questions about MDR or how Maasleder complies with this legislation? If so, feel free to get in touch! We are happy to answer your questions and to share ideas constructively about your own MDR compliance.

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