Cybersecurity in the MDR and IVDR

On  31.07.2023 Cyen’s Iva Tasheva and Eva Saeva escribe the cybersecurity requirements under the Medical Devices Regulation (MDR) & the In Vitro Diagnostic Medical Devices Regulation (IVDR). They also touch upon the interrelation between the obligations under these two regulations and the other EU cybersecurity laws applicable to the health sector and the medical devices manufacturers.