Allmed becomes the first fully MDR compliant haemodialysis product producer in Europe, the Middle East and Africa (EMEA) region
Compliance with EU Medical Devices Regulation (MDR 2017/745) certified by the British Standards Institution (BSI) auditing body
LONDON, UK; 15 June, 2022 – Allmed Medical GmbH, part of Allmed Group (“Allmed” or “the Company”), a producer of end-to-end haemodialysis solutions, today announces that it has received Medical Device Regulation (EU MDR 2017/745) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of the Company’s haemodialysis products in Europe.
With the certification, Allmed has become the first haemodialysis products producer in the EMEA region to accomplish and certify full MDR compliance on its medical devices.
Ahmed Sorour, Chief Executive Officer at Allmed Group, said: “Allmed’s mission is to make a meaningful difference to people living on dialysis and receiving MDR certification means that we will continue to do so. Becoming the first fully compliant haemodialysis product producer in the EMEA region is a testament to our commitment to delivering high quality, safe solutions to haemodialysis patients, and I am proud of the many months of hard work and commitment by Allmed’s Total Quality Management team.”
Haydar Jaafar, Operations Delivery Director at BSI, commented: “We are delighted to issue the essential MDR certificates to Allmed Medical GmbH, who have prioritised working to the new, more stringent MDR requirements. This achievement is a testament to their commitment to ensuring innovation remains at the forefront of their product development. These life-saving products will support patient safety at a critical time and are a sign of the resilience of our industry.”
The certificate, valid until 2027, will be officially registered on the European Database of Medical Devices and covers the following product groups, which are major components of Allmed’s dialysis portfolio:
- Hollow fibre haemodialyzer “POLYPURE® Family sterilized by Steam and Gamma” 2. Hollow fibre haemodialyzer “BIOREMA® Family sterilized by Steam and Gamma” 3. Arterial Venous Bloodlines “Sterilized by Gamma and ETO”
- Sodium Bicarbonate Cartridge “Non-sterile product”
- Dialysis Cleaning/Disinfection Cartridge “Non-sterile product”
- Infusion Set “Sterilized by Gamma and ETO”
Additionally, Allmed has successfully passed all MDR-related Quality Management System (QMS) audits and has been granted the corresponding certificate (BS EN ISO 13485:2016+A11:2021) valid until 2025.