Analysis of the impact of clinical evaluation on the submissions of high risk medical devices to the Brazilian Health Regulatory Agency

Abstract

Introduction: The clinical evaluation of medical devices is an important component in the evaluation of new technologies for sanitary registration purposes within the Brazilian Health Regulatory Agency and represents an important tool for regulatory decision-making to verify compliance with regulations that establish the need for proof of safety and efficacy of medical devices to perform sanitary registration. Objective: To evaluate and discuss the reasons for the rejection of registration requests motivated by deficiencies related to the clinical evaluation of high-risk medical devices. Methods: In the electronic system Datavisa, internal system for storage and analysis of data submitted to Anvisa, all the rejections occurred in 2017 within the scope of the General Office of Medical Devices (GGTPS) concerning the clinical evaluation of medical devices of risk class III and IV, both in the original cause of the refusal and related to the non-compliance with the legally established deadlines for meeting the requirements when at least one of the requirements involved clinical evaluation, were evaluated. Results: Data were collected from the expert opinion of the agency to construct the outline of the main characteristics related to the rejections in relation to the clinical evaluation offered in the registration dossiers by the companies responsible for the submission. The evaluations were divided according to the area responsible for the registry, involving implantable orthopedic materials submitted to the analysis of the Coordination of Implantable Materials in Orthopedics (CMIOR), materials for health use submitted to the analysis of the Office of Materials for Health Use (Gemat) and equipment submitted to the analysis of the Office of Equipment Technology (GQUIP) of Anvisa. Conclusions: Considering the sample of rejected health records, the findings suggest a heterogeneity in both the quality and the format of the data provided in clinical evaluations by companies submitting applications of medical devices, especially related to the methodological nature of the clinical trials presented, deficiencies in risk management, and other regulatory requirements connected to the clinical assessment scenario of medical devices and compliance with minimum design requirements.