Software
Software is today essential for the functioning of products. Under the medical device and in vitro medical devices legislation, software in its own right presenting certain features is considered as a medical device or an in vitro diagnostic medical device (41). Certain pieces of Union harmonisation legislation refer explicitly to the software integrated in the product (42). As part of the initial risk assessment, the manufacturer of the final product has obligations to foresee the risks of software integrated in that product at the time of its placing on the market. The concept of product safety encompasses protection against all kinds of risks arising from the product, including not only mechanical, chemical, electrical risks but also the safety-related aspects of cyber risks and risks related to the loss of connectivity of devices. Software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.