Health hazards are evaluated according to 4 elements :

Health watching that monitors the risks likely to appear at the origin of possible therapeutic accidents.

Initial evaluation: medical research, authorisation to put on the market and CE marking.

Vigilance, a consequence of the initial evaluation that makes it possible to detect all incidents or undesirable effects not detected at the time of the initial evaluation and which constitute an information or observation mechanism for health authorities.

Verification at hospital level: doctors when prescribing and pharmacists when providing dispensing advice.

These four elements make it possible to evaluate the advantage/risk ratio, the basis on which decisions in the area of health safety are taken. Vigilance as regards MD is materiovigilance (public health code art. R 665-48): surveillance of iatrogenic risks linked to medical devices and systems.

Law n°98-535 of 1st July 1998 reinforcing health watching and verification that products intended for human use present no health hazard by :

The setting-up of a National Committee for Health Safety whose task is to analyse events likely to affect the health of the population, ensure the co-ordination of scientific policy of the Institut de Veille Sanitaire [Health Watch Institute] and French agencies for health safety of health and food products.

The setting-up of a Health Watch Institute whose task is to survey the population's state of health and changes in this, to alert the public authorities in the case of threat for public health and to carry out all appropriate actions, and to group, analyse and enhance knowledge of health risks, causes and changes.

The setting-up of a French Agency for Health Safety of Health Products that replaces the Medicament Agency since March 1999 with tasks widened to cover new products, including medical devices. Among its tasks it must guarantee the independence, the scientific competence and the administrative efficiency of studies and verifications relating to tests, manufacture and different marketing processes and the use of products for health purposes in humans, and participate in the application of laws and regulations relating to these products.

Concerning medical devices, art.14 of the law of 1 July 1998 specifies that these can only be imported, put on the market, put into service or used if they have previously received a certificate attesting to their performance and their conformity to essential requirements concerning the safety and health of patients, users and third parties.