The MDs must be designed and manufactured in such a way that their use does not jeopardise the patients' clinical condition and health, or the security and health of the surgical team. They must not present risks for those who handle them when they are used in conditions and for the purposes for which they are intended. They must also achieve the performance that is assigned to them by the manufacturer. The manufacture and packaging of the devices must ensure that their characteristics and performance are not damaged in the storage and transport conditions specified by the manufacturer.

The main risks that must be eliminated or minimised are the risks linked to the toxicity of the materials and their incompatibility with biological cells and tissues, the risks of infection for the patient, the user or third parties when handling, the risks linked to the physical characteristics of the devices and those linked to reasonably foreseeable environmental conditions (magnetic fields, electrical influences, pressure, temperature, etc.), the risks resulting from the ageing of the materials used or the decrease in the precision of a verification or measuring mechanism; and the risks linked to the emission of non-intentional rays.

The requirements also concern :

the sterilisation conditions

the instructions appearing on a device

the indications to be systematically indicated on the wrapping ensuring the sterility and/or commercial wrapping

the contents of the instructions leaflet