Portuguese Institute for Quality, Unit of Legal Metrology, Rua C. à Av. dos três Vales, 2825 Monte de Caparica, Portugal
Medical measurements are present in the everyday life of people and are fundamental processes in prevention, diagnosis and treatment of disease. Therefore, a growing interest lies in the role of metrological decisions and conformity assessment, namely where measurements are in support of health. This paper focuses on the use of medical devices looking to enhance its metrological traceability, highlighting the specific role of metrology in the field of health care and the impact of legal control in the framework of the medical devices regulation with a measuring function. It is proposed a new regulatory approach for medical devices in use, facing the convergence between European policy enforcement and Metrological regulations.
(Received April 26 2011)
(Accepted August 10 2011)
(Online publication January 10 2012)