World Health Organisation

Medical devices are articles or instruments used in disease prevention, diagnosis, or treatment. Medical devices range in form and function, ranging for instance from inhalers to pacemakers to magnetic resonance imaging (MRI) machines, etc.

Risk factors are those factors linked to poor health, disability, disease, or death. Generally, risk factors can be classified as behavioural, physiological, demographic, environmental, or genetic. Reducing exposure to risk factors would improve global health and life expectancy.

Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product enters the market.

Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes into the public domain via a number of routes.

The EMA Committee for Advanced Therapies (CAT) reviews the quality, safety, and efficacy of Advanced-Therapy Medicinal Products (ATMPs).