Section 5: Essential health and safety requirements.

The provisions of article R. 5211-21 are applicable to in vitro diagnostic medical devices.

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,…

For the application of this section, orders issued by the Minister for Health, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, shall specify the conditions for implementing the essential requirements defined in Articles R. 5221-15 and R. 5221-16.