• controlled release
• intrauterine device
• pH sensitive hydrogels
• smart medical device.

Traditional contraceptive methods based on intrauterine devices typically results in woman being constantly exposed to hormones or copper. The aim of this study is the design of an intrauterine device able to modulate copper ions release thanks to pH-sensitive hydrogels. The functioning principle exploits physiological pH variations in the vaginal fluids, which increases from pH 3.5-4.0 up to 7 during intercourse. Medical devices are subject to strict approval processes, thus considering regulatory aspects starting from the device design concept is essential. Using the UBORA platform, the device was classified as Class III. Standards for compliance with Medical Device Regulation were identified accordingly. Computational and experimental tests were performed on polyacrylamide and chitosan hydrogels to assess the feasibility of this technological solution.