OBJECTIVES: The National Committee for Health Technology Incorporation (CONITEC) published a methodological guideline for evaluating Medical Devices (MD) in 2013, including fifteen criteria in 5 domains. However, these specific criteria for devices have not been widely used. This work evaluates the utilization of MD assessment criteria in CONITEC reports and factors related to this utilization.

METHODS: All MD health technology assessment reports produced by CONITEC between June 2013 and December 2023 were obtained from the agency's website, excluding clinical tests, formulas, food supplements, molecules, and unavailable reports. Fifteen criteria were evaluated in 5 domains, reflecting the guidelines: CLINICAL (Literature Review, Facilitators, and Barriers); TECHNICAL; OPERATIONAL (Human Factors and Ergonomics, Workplace Safety, Usability, Training, Learning curve, Infrastructure, Accessories, Maintenance, Risk Factors, Sustainability); ECONOMIC (Health Economics) and INNOVATION DOMAIN. Each report gained 1 point per criterion appropriately mentioned. The maximum score would be 15/15.

RESULTS: In total, 60 reports were evaluated; 15 were classified as diagnostic and 43 as therapy. The most analyzed criterion was Health Economics (57/60), followed by Literature Review (56/60) and Technical (55/60). The least analyzed criteria were Sustainability (0/60), Ergonomics (2/60), and Workplace Safety (3/60). The average score across reports was 6/15. The average varied according to the year of publication, varying from 4.4/15 in 2014 to 8.4/15 in 2023. The rate was not different between industry (5.2) and internal (5.7) submissions; however, the percentage of positive recommendations was higher for internal submissions (82%), compared to industry (40%).

CONCLUSIONS: CONITEC reports’ methodology has visibly improved over the years. In the MD area, this improvement emerged mainly after the division of the plenary into committees (2022). However, it is still necessary to improve assessments, based on clear criteria specific to MD, since the evidence for MD is different from pharmaceutical products.