Digital solutions contribute to transforming Health processes into health and improving management and efficiency. Now, The digitalization of the health system must be done safely and ethical. Cataloging as a health product and obtaining CE marking is a guarantee that all those technological tools that apply in the field of health have exceeded the procedures marked by health regulations.
When software is classified as a health product and what is the certification process to follow? To these and other issues, response has been given in the day ‘Software regulation as a health product’ Organized by the Spanish Federation of Health Technology, Fenin, and the Association of Digital Health (ASD) at the Dentons headquarters in Madrid.
“Technological innovation improves the health and quality of life of people. Digital health solutions used in hospitals increase their productivity, help solve challenges such as lack of health professionals and even allow these centers to the patient’s home. The value provided by the CE marking of health product is essential in any digital tool and/or software applied in health, ”he said Ignacio López, President of the Digital Health Sector of FENIN. “With initiatives such as this day, from FENIN we contribute to the professionals who work in the development of software for the health environment know this importance and the procedures to be taken into account,” he said.
For its part, Jaime del Barrio, President of ASD, has indicated that “the certification, which includes the CE marking under the Sanitary Products Regulation (EU) 2017/745 known as MDR (Medical Device Regulation) since its entire entry into force on May 26, 2024 and multiple effects in this 2025, guarantees that the software complies with the safety, efficiency and quality standards necessary for its use in medical environments. The software cannot be used for medical purposes, since it is not assured that it complies with the current regulations and the safety requirements necessary to protect the health of patients ”. In addition, “the certification provides a regulatory compliance guarantee, which is crucial for the confidence of managers, health professionals and patients in the technology used,” he added from the neighborhood.
Vision of regulatory entities
On this day, representatives of the Spanish Agency for Medicine and Health Products (AEMPS) and the National Center for Health Products Certification (CNCPS) have approached in depth What is a health product, When software can enter the category of health product, the different levels of classification, and the certification process to follow.
These interventions have been completed with the exposure of success cases of companies that have certified their software for health application.
