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European Renal Association

ERA

With more than 28,000 members, the ERA (“European Renal Association”) is one of the biggest nephrology associations worldwide and one of the most important and prestigious European Medical Associations.

Lobbying Activity

Response to EU cardiovascular health plan

15 Sept 2025

The European Renal Association (ERA) strongly welcomes the upcoming EU Cardiovascular Health Action Plan. Recognising that cardiovascular disease (CVD) serves both as a leading health burden in itself and as a critical risk factor for chronic kidney disease (CKD) and other metabolic conditions, we fully support the EUs coordinated efforts to curb CVD morbidity and mortality. The prevalence of CKD is rising rapidly850 million people worldwide(1)100 million in Europe.As highlighted by the WHO(2) CKD is among the fastest-growing causes of death, projected to be the third leading cause in high-income countries by 2050(3). Most of the increased mortality risk observed in patients with CKD is due to CVD(4-5). Indeed, CKD is a potent and independent risk factor for CVD.Individuals with CKD face elevated risks of developing CV death, coronary artery disease, stroke, heart failure, atrial fibrillation, peripheral vascular disease and sudden cardiac death(6-7-8). Increased CV risk begins with even low levels of renal impairment and in people with normal kidney function and mildly increased albuminuria.The risk then increases exponentially with both worsening renal function and increasing albuminuria with the highest risk in those with both(4-5).There is a biological plausibility underlying a cause-and-effect relationship between CKD and CVD, supported by clinical trials(9-10-11-12-13). Among patients with advanced CKD (stages 4-5), the prevalence of CVD is ~50%, with CV causes accounting for 4050% of total mortality, compared with 26% in the general population(14). Thus, CKD should be regarded both as a likely consequence of CVD and as a crucial contributor to the overall CVD burden. This has been recognised by the European Society of Cardiology and 12 European Scientific Societies, which identified CKDalong with diabetes and familial hypercholesterolaemiaas three conditions requiring targeted primary prevention to reduce CVD risk(15-16).The American Heart Association conceptualised the Cardiovascular-Kidney-Metabolic (CKM) syndrome to emphasise the close links between overweight-obesity-type 2 diabetes mellitus-kidney health-CV health(17). It is imperative that CVD, CKD and diabetes be addressed in an integrated manneras CKM syndrometo effectively tackle the shared and interrelated drivers of CV and related conditions, as recommended by cardiology(15-17), diabetes and renal(6-16) scientific associations, the Council(7) and the WHO(2). The ERA has recently developed the ABCDE framework for the holistic assessment of CKM health that can be adapted to the different national health care systems. ABCDE stands for -Albuminuria -Blood pressure -Cholesterol -Diabetes (i.e., glycemia) -Estimated glomerular filtration rate(4-5-16-18) i.e., for one urine test, one physical examination feature, and three blood analytes that allow to correctly fit individuals into major categories in the CKM spectrum requiring specific drug interventions for the primary prevention of CVD, according to the 2021 ESC guidelines(15). It summarises the CKM assessments that should be provided by the healthcare system, as other key elements to assess CKM health can be self-assessed such as the body mass index, the smoking status and lifestyle. In conclusion, all patients at risk of CKD should be screened for CKM health using the ABCDE approach: (A)Albuminuria: readily quantifiable from a spot urine sample as the urinary albumin:creatinine ratio (uACR); (B)Blood pressure: measured as per national or international guidelines (eg ESC BP Guidelines); (C)Cholesterol: lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides); (D)Diabetes: random and/or fasting plasma glucose in addition to a HbA1c measured in a blood test; (E)Estimated glomerular filtration rate; calculated from a serum creatinine using a validated equation. Evidence shows that screening for CKD using albuminuria is cost-effective, at least in those aged >45(19) (Refs. attached)
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Response to Establishment of an expert panel on orphan and paediatric devices

12 Jun 2025

As Chairs of the EUDIAL working group of the European Renal Association focused on dialysis in Europe, we are deeply concerned about the impact of the EU Medical Device Regulation (EU MDR 745/2017) on the current and future availability of suitable medical devices required to provide dialysis treatment, as well as on the direct and indirect effects on innovation in this life-saving field of medicine. One specific area confronted by a critical shortage of suitable devices and materials is paediatric nephrology. There is an acute lack of suitable dialysis machines and catheters to safely perform life-saving long-term haemodialysis (HD) and peritoneal dialysis (PD) treatment in young children. Paediatric nephrologists are increasingly forced to treat children with off-label dialysis machines and catheters making the practice unsafe and suboptimal. For example, in case of HD, none of the machines currently available are labelled for children under 10 kg body weight and many techniques to improve dialysis treatment and long-term outcomes have not been adapted for children below 40 kg. The technical prerequisites needed to safely perform HD in small children are scarce dialysis machines and catheters require specific design adapted to the needs of small children, and cannot simply be miniaturised versions of adult devices. Similar shortage has developed regarding PD equipment. Importantly, the knowledge and technology to design and manufacture the necessary equipment to perform safe and high-quality dialysis treatments are available, but incentives and mandates on device manufacturers are needed. Paediatric nephrologists have been struggling for several months to avoid shortage of these life-saving devices, by contacts with manufactures and exchanges between centres within Europe. This concerns 40.6 children per million age-related population (range: 8.9 to 94.6) according to the 2022 European Society of Paediatric Nephrology Registry. The EU Medical Device Regulation (EU MDR 745/2017) addresses an important issue of improving safety of medical devices, but has hugely increased the time and cost burden associated with bringing these to the market or maintaining them on the market. As a result, manufacturers are discontinuing the marketing of medical devices that are sold only in small numbers. There is a high likelihood of further losing a significant number of essential dialysis devices from the EU market including dialysis machines, optimisation features and software in machines, filters, and catheters. Development of innovative paediatric dialysis devices is extremely challenging under existing regulations. Doctors and nurses are increasingly forced to use suboptimal or even inadequate dialysis techniques which can result in serious life-threatening risks or even avoidable death. On behalf of the EUDIAL working group we ask the EU to urgently address the serious shortages of medical devices for life-saving dialysis in children, mitigate the further threats to innovation and availability, and to develop a robust system to promote innovation and free availability of life-saving medical devices for our most vulnerable population. Yours sincerely Prof. Dr. Em. C. Combe Prof. Dr. B. Meijers Chair EUDIAL Co-Chair EUDIAL Université de Bordeaux KU Leuven France Belgium
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