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: 

  1. 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” 
  2. Sodium Bicarbonate Cartridge “Non-sterile product” 
  3. Dialysis Cleaning/Disinfection Cartridge “Non-sterile product” 
  4. 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.