Medical Devices

Medical Devices are important health devices, which encompass a wide range of products. They are intended by their manufacturer to be used for purposes common to medicines, such as preventing, diagnosing or treating a human disease. They must achieve their ends through mechanisms that do not translate into pharmacological, metabolic or immunological actions, so they are distinguished from medicines.

- Preparation of technical dossiers

- Elaboration of expert reports

- Preparation of documentation to request conformity assessment of active, non-active and in vitro diagnostic medical devices

- Classification

- Procedures for obtaining the CE conformity marking

- Surveillance