Chapter I: Legal status of in vitro diagnostic medical devices.

I.-The criteria for classifying a situation as a risk in the management of a patient's state of health due to the unavailability of an in vitro diagnostic medical device are laid down by regulation.

The manufacturers of the in vitro diagnostic medical device or their agents or any person involved in its import or distribution, excluding retail sales, or, failing this, the Agence nationale de sécurité du médicament et des produits de santé, after consulting the operators, may make this classification.

II.- In the situations referred to in I, the manufacturers of an in vitro diagnostic medical device or their agents or any person involved in its import or distribution, excluding retail sales, who take the decision, after consulting the operators, may take the decision.In the situations referred to in I, manufacturers of an in vitro diagnostic medical device or their agents or any person involved in its import or distribution, excluding retail sales, who take the decision to suspend or cease its marketing or who are aware of facts likely to lead to the suspension or cessation of this marketing, shall inform the Agence nationale de sécurité du médicament et des produits de santé, in accordance with the procedures defined by regulation.

III. -When the assessment carried out under I reveals a risk in the management of the patient's state of health, the manufacturers or their agents or any person who imports or distributes this device, excluding retail sales, shall implement, in accordance with the procedures defined by regulation, any useful and necessary advance measure aimed at ensuring the continuity of the management of the patient's state of health in his or her interest.

IV. -In certain situations identified in I, or where the measures mentioned in III have not enabled the risk to the patient's state of health to be avoided, manufacturers or their agents or any person who engages in import or distribution, excluding retail sales, shall make a declaration to the Agence nationale de sécurité du médicament et des produits de santé of the risk of rupture or any rupture relating to this in vitro diagnostic medical device, under conditions defined by regulation.

V.-When it notes a risk of disruption or a disruption in the availability of an in vitro diagnostic medical device leading to a situation identified in I, for which the manufacturer or its authorised representative or any person engaged in import or distribution, excluding retail sales has not implemented the measures referred to in III or has not made the declaration referred to in IV, the Agence nationale de sécurité du médicament et des produits de santé shall take any useful and necessary measure to avoid the disruption and ensure continuity of the patient's state of health in his interest. These measures are taken after consultation with the aforementioned operators, healthcare professionals and associations of patients and users of the healthcare system.

Information relating to the qualifications of situations linked to the unavailability of in vitro diagnostic medical devices, to the identified risks of disruption in their availability and to the anticipatory measures taken is kept at the disposal of the Agence nationale de sécurité du médicament et des produits de santé and is sent to it at any time at its request.