Following the entry into force of Royal Decree 942/2025 on in vitro diagnostic (IVD) medical devices, the Federación Española de Empresas de Tecnología Sanitaria, Fenin, wishes to state the following:
- The approval of this legislative provision was necessary for the correct implementation of European Regulation 2017/746 on IVD medical devices—specifically, to regulate those aspects that this regulation entrusts to Member States and to repeal the national standard in force since 2000 (RD 1662/2000).
- Healthcare Technology companies have already been making a significant investment effort in human and economic resources to comply with the requirements of European Regulation 2017/746. Therefore, the application of the new RD 942/2025 must not generate unjustified additional costs for companies.
- In this regard, the Federation will continue to work with administrations so that companies can swiftly implement the measures introduced in the Royal Decree and to ensure they do not act as a brake on technological innovation. The objective is to ensure at all times the availability for the healthcare system, professionals, and patients of essential medical devices for the prevention, diagnosis, and treatment of diseases.
- Fenin views positively that this RD regulates everything related to “in-house” manufacturing of medical devices by hospitals and healthcare centers: from the clarification of the concept (what is understood by “in-house” manufacturing) to the reinforcement of the conditions and requirements for carrying out this activity.
- Fenin recognizes the value of “in-house” manufacturing of medical devices to respond to particular healthcare needs of patients when no industrial alternative is available on the market. However, the Federation wishes to recall that before manufacturing an “in-house” product, the healthcare center must examine the market to investigate the presence and availability of an equivalent CE-marked product and, additionally, justify why patient needs cannot be met by a commercialized product, taking into account that, according to the European regulation, this requirement applies from December 31, 2030.
- Although certain legislative requirements demanded of manufacturers cannot be applied to medical devices manufactured in healthcare centers, the Healthcare Technology sector believes that the manufacturing of medical devices in a healthcare center should have the same levels of safety and quality as any product manufacturer and should be subject to the same inspections and controls. The requirement for inspections and controls is the healthcare guarantee that whoever manufactures a medical device possesses the material and human resources and has implemented procedures for the safe and effective use of the products.
Fenin reiterates its commitment to working with administrations on an effective application of this RD 942/2025, which does not slow down the swift incorporation of innovation into the system, does not generate additional costs on the investments already made by this industry, and, ultimately, ensures the availability at all times for professionals and patients of IVD medical devices essential in the management of pathologies, and the improved health and quality of life of the population.