Under Regulation (EU) 2017/745 (MDR), a medical device is any instrument, apparatus, equipment, software, implant or other article intended by the manufacturer for medical use in humans: diagnosis, prevention, monitoring, treatment or alleviation of a disease. No text currently requires manufacturers to carry out an LCA, and medical devices are excluded from ESPR and the Digital Product Passport. Yet LCA is becoming necessary for those selling to hospitals: public contracts have been required to include an environmental criterion since August 2026, and the DGE is consulting until 16 October 2026 on a method for assessing medical devices’ carbon footprint.
Read the source article: Medical device carbon footprint: figures and LCA