Section 5: Essential health and safety requirements.

In order to comply with the requirements relating to design and manufacture, in vitro diagnostic medical devices are designed, manufactured and packaged in such a way as to meet the following objectives:

1° To have chemical and physical properties which make it possible to guarantee the characteristics and performance referred to in Article R. 5221-15 and to reduce as far as possible the risk to personnel involved in the transport, storage and use of the devices, taking into account their intended purpose, from product leaks, contaminants and residues;

2° To eliminate or reduce to a minimum the risk of infection and microbial contamination for the user, any other person or the sample coming from the human body and having to be examined, in particular when the device contains biological substances and is maintained in its packaging at the level of cleanliness or in the particular microbiological state indicated by the manufacturer;

3° Minimise the risks associated with their use in conjunction with the materials, substances and gases with which they may come into contact during their normal use, the risks of injury associated with their physical characteristics and the risks associated with foreseeable external influences, and guarantee immunity against electromagnetic disturbances enabling them to function in accordance with their intended purpose;

4° Provide, if they are devices with a primary analytical measurement function, adequate constancy and accuracy of measurement, taking into account the intended purpose of the device and the available and appropriate reference measurement procedures and materials;

5° With regard to protection against radiation, reduce to a minimum the exposure of users and other persons to radiation emissions, ensure that the characteristics and quantity of the radiation emitted can be controlled and regulated, and include detailed information on the nature of the radiation emitted, the means of protecting the user and on ways of avoiding incorrect operation and eliminating the risks inherent in the installation;

6° To reduce to a minimum, if they are connected to or equipped with an energy source, the risks of creating electromagnetic disturbances, accidental electric shocks and mechanical and thermal risks;

7° In the case of devices intended for self-diagnosis, have performances commensurate with their intended purpose, taking into account the skills and resources available to users and the variations that can reasonably be expected in the technology and environment of users, and present the information and instructions supplied by the manufacturer in such a way as to make them easy for the user to understand and apply;

8° Be accompanied by the information necessary to enable it to be used correctly and safely, taking into account the training and knowledge of potential users, and to identify the manufacturer. The list of information that must appear on the labelling and in the instructions for use is set, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health.