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00925njm 22002777a 4500 dc Serrano-Aguilar, Pedro author Gutierrez-Ibarluzea, Iñaki author Díaz, Pilar author Imaz-Iglesia, Iñaki author Gonzalez-Enriquez, Jesus author Castro, José Luis author Espallargues, Mireia author García-Armesto, Sandra author Arriola-Bolado, Paloma author Rivero-Santana, Amado author Perestelo-Pérez, Lilisbeth author González-Pacheco, Himar author Álvarez-Pérez, Yolanda author Faraldo-Vallés, María José author Puñal-Riobóo, Janet author Ramallo-Fariña, Yolanda author Sanchez-Gomez, Luis Maria author Asua-Batarrita, José author Reviriego-Rodrigo, Eva author Moreno-Rodríguez, Anai author Juárez-Rojo, Celia author Vicente-Saiz, Marisa author Orejas-Pérez, Eugenia author Knabe-Guerra, Jutta author Prieto-Yerro, Isabel author González Del Yerro-Valdés, Cristina author 2021-05-04 The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels. Int J Technol Assess Health Care. 2021 May 4;37(1):e63. 10.1017/S0266462321000295 1471-6348 International journal of technology assessment in health care 33942712 http://hdl.handle.net/20.500.12105/14545 Decision making Europe Postlaunch evidence-generation studies Real-world evidence Technology assessment Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making