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”
Hollow fibre haemodialyzer “BIOREMA® Family sterilized by Steam and Gamma”
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.
About Allmed Group
Allmed Group is a global producer of end-to-end haemodialysis product solutions. It is headquartered in London and has product development and manufacturing operations in Germany and in Egypt. In addition, it has direct sales, marketing & distribution operations in the UK, Brazil, Egypt, Turkey, Poland, Germany and India. The Group employs more than 1,300 staff world-wide and exports to more than 40 countries across the globe.
About European Medical Device Regulation (MDR)
The MDR 2017/745 came into effect in May 2021, replacing the former European Directives for medical devices (AIMDD 90/385/EEC and MDD 93/42/EEC). It is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of safety and health whilst supporting innovation. EU MDR has significantly increased the requirements in respect of technical documentation, risk management approach, benefit-risk evaluation, Unique Device Identification (UDI), Economic Operators, clinical evaluation, vigilance, trend reporting and post-market surveillance, with more stringent scrutiny of Competent Authorities and Notified Bodies. It represents the biggest change in European medical device compliance standards in more than 20 years.
For further information, please contact:
Consilium Strategic Communications
Matthew Neal/ Davide Salvi/ Lucie Foster