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Dear sir or madam,
we would like to thank you for launching the call for evidence to identify possible well-established technologies (WET). We greatly appreciate that you are giving the scientific and clinical community the opportunity to nominate devices, that should be added to the designated list of technologies that, because they are WET, will benefit from simplified conformity assessment procedures and/or be exempted from the requirement to conduct a clinical investigation. The German Society of Nephrology (DGfN), as an association dedicated to the scientific and professional needs of patient care in kidney disease, has a strong interest in providing safe and high-quality treatment for the benefit of our patients. The health and safety of our patients is of paramount importance. The devices and systems currently available on the market for clinical use have been in use for a long time and have been further developed based on the experience gained from their use. They are well established and have been proven to be safe over several decades and therefore meet the requirements of the EU Commission. As they are used every day by millions of patients worldwide, there is no need for further data collection in clinical trials.
We are convinced that the listed devices will greatly benefit from simplified conformity assessment procedures, increasing the likelihood that these WET will remain fully accessible for patient care. We attach the greatest importance to ensuring that the supply of products in the groups outlined in the attachment is and will continue to be guaranteed. Please find attached the list of WET in Nephrology. Your support is greatly appreciated.
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