Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease
For example: medical imaging, surgical devices, medical monitors, etc.
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
For example: orthopedic soles, wheelchairs, prostheses
- investigation, replacement or modification of an anatomy or of a physiological or pathological process or state
- providing information by means of in vitro examination of specimens derived from a human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products are also deemed to be medical devices:
- devices for the control or support of conception
- products specifically intended for the cleaning, disinfection or sterilization of devices
- other products not having a medical purpose.
For example: contact lenses, substances or combinations of substances intended to be used for facial or other dermal or mucous membrane filling, products intended to be totally or partially introduced into the human body through surgically invasive means.
In addition, an in vitro diagnostic medical device is defined as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system intended by the manufacture to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, only or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state
- concerning congenital physical or mental impairments
- concerning the predisposition to a medical condition or a disease
- to determine the safety and compatibility with potential recipients
- to predict treatment response or reactions
- to define or monitoring therapeutic measures.
For example: pregnancy tests, blood sugar tests, HIV tests, etc.
Specimen receptacle are also deemed to be in vitro diagnostic medical devices.
Note: products intended for general laboratory uses are not considered as in vitro medical diagnostic devices unless, with regard to their characteristics, they are specifically intended by their manufacturer for in vitro diagnostic tests.
Obligations and controls
Medical devices cannot be placed on the market or put into service unless they meet regulatory requirements, when they are duly supplied and properly installed, maintained, and used in accordance with their intended purpose.
The doctors of the Health Directorate conduct controls to ensure compliance with these requirements.
Medical devices, active implantable medical devices, and in vitro medical diagnostic devices must comply with the legally specified requirements. Consequently, the marketing, intra-Community movements, importing or exporting of these products is subject to CE marking and related conformity inspections.
The product is free to circulate if the CE marking is applied.
On export, certain countries may require a free sale certificate.
Applications for certificates of free sale for medical devices should be sent to the medical devices office of the Pharmacy and Medication Department at firstname.lastname@example.org regarding medical devices or at email@example.com for in vitro diagnostic medical devices.
The Pharmacy and Medication Department of the National Health Directorate is the competent authority for the surveillance of medical devices, among other duties.