The European Union (EU)'s new regulatory framework of the Medical Device Regulation (MDR) came into force today, and the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) has offered a review of the rules in a position paper.
One important aspect is that medical devices must comply with a plethora of other EU legislation, according to the COCIR. Current discussions on cybersecurity requirements under the Radio Equipment Directive or the future Artificial Intelligence Act highlight how the complexity of various regulations requires constant vigilance to avoid duplications and unnecessary burden on manufacturers, it says.
The barriers to the harmonization of standards are another example of the impact of horizontal EU action on the placing on the market of medical devices.
For more details on the paper, go to the COCIR website.
![Overview of the study design. (A) The fully automated deep learning framework was developed to estimate body composition (BC) (defined as subcutaneous adipose tissue [SAT] in liters; visceral adipose tissue [VAT] in liters; skeletal muscle [SM] in liters; SM fat fraction [SMFF] as a percentage; and intramuscular adipose tissue [IMAT] in deciliters) from MRI. The fully automated framework comprised one model (model 1) to quantify different BC measures (SAT, VAT, SM, SMFF, and IMAT) as three-dimensional (3D) measures from whole-body MRI scans. The second model (model 2) was trained to identify standardized anatomic landmarks along the craniocaudal body axis (z coordinate field), which allowed for subdividing the whole-body measures into different subregions typically examined on clinical routine MRI scans (chest, abdomen, and pelvis). (B) BC was quantified from whole-body MRI in over 66,000 individuals from two large population-based cohort studies, the UK Biobank (UKB) (36,317 individuals) and the German National Cohort (NAKO) (30,291 individuals). Bar graphs show age distribution by sex and cohort. BMI = body mass index. (C) After the performance assessment of the fully automated framework, the change in BC measures, distributions, and profiles across age decades were investigated. Age-, sex-, and height-adjusted body composition reference curves were calculated and made publicly available in a web-based z-score calculator (https://circ-ml.github.io).](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/05/body-comp.XgAjTfPj1W.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
