Haag-Streit UK’s quality management commitment ensures compliance with UK MDR, EU MDR, and International Standards.
We are registered and regulated by our UK Competent Authority, the MHRA, as a manufacturer of medical devices. Haag-Streit UK’s products conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and hold the UKCA mark for all products. We supply quality assured CE marked products to the EU and all our products conform to the requirements of the EU Medical Directive 2017/745 as amended to Regulation (EU) 2023/607.
We are annually audited by both our approved body SGS UK Ltd 0120 and our notified body SGS Belgium NV 1639 to ensure compliance with applicable standards and regulations.
We operate a full quality management system which is audited to meet international standard ISO 13485:2016 and MDSAP, the world’s most widely recognised quality management system standard for medical devices, allowing us to continually monitor and manage our company procedures and quality across all our operations.
This page contains electronic Adobe Acrobat PDF files of quality certificates, conformity documentation, and instruction for use (IFU) material for Haag-Streit UK manufactured products, including Haag-Streit UK ophthalmic devices and John Weiss surgical instruments.
It also contains important Haag-Streit UK corporate policies, such as our Carbon Reduction Plan, Social Value Policy, Modern Slavery Statement, and Environmental and Sustainability Policy and Procedure.
Please click on one of the tabs below to view and download the relevant PDF file.
