French CA issues procedure deal with risks of rupture of essential medical devices and IVDs.
The French National Agency of Medicines and Health Products Security (ANSM) has recently published a special management procedure for market operators to prevent a shortage of medical devices and in-vitro diagnostic devices.
As France does not currently have a legal framework deal with the issue, the new management framework gives more clarity on the steps to follow in case of a rupture in the supply chain, or the risk of it. This applies to medical devices and IVDs referred to by the ANSM as ’indispensables’, which they define as “those whose absence could have an impact on patient care” (ANSM, 2021).
Moreover, the ANSM has also prepared a guideline for completing the declaration form, clarifying that the procedure concerns devices that “are considered to be essential for the pathologies concerned, for example, because of its captive nature, without alternative, or a majority market share” (ANSM, 2021).
Additionally, through this procedure, the ANSM aims at preventing future risks and dealing with ruptures in the supply chain, to provide end-users with alternative solutions as soon as possible. The procedure carried out involves two main stages:
1.In the first stage, the manufacturer of the product has to implement an action plan focused on dealing with the lack of devices. Examples of measures taken are the following:
· Contingency measures;
· Increasing production capabilities;
· Identifying alternative solutions.
2. Only if these actions are insufficient in ensuring the availability of such devices on the market, the distributor, importer, manufacturer, or a body mandated by the latter must send the ANSM a special declaration (‘declaration de rupture’). This informs the authority of the context and actions taken and triggers its direct involvement in finding alternative solutions to be provided to the end-users.
To facilitate this procedure for manufacturers, the ANSM also provides a decision tree on the existing ways to treat ruptures medical devices and IVDs stocks, an explanatory index, and a guide on how to fill in the declaration. All these documents are publicly available on their website in French.
Do you wish to know more about national competent authorities’ requirements? Please do not hesitate to contact us.
Pablo De Mingo
Regulatory Affairs Department
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ANSM (2021). Assurer la sécurité des produits de santé. Retrieved on 21/09/2021 from https://ansm.sante.fr/qui-sommes-nous/nos-missions/assurer-la-securite-des-produits-de-sante/p/assurer-la-disponibilite#title
ANSM (2021). Notre périmètre: Les dispositifs médicaux et les dispositifs médicaux de diagnostic in vitro. Retrieved on 21/09/2021 https://ansm.sante.fr/qui-sommes-nous/notre-perimetre/les-dispositifs-medicaux-et-les-dispositifs-medicaux-de-diagnostic-in-vitro/p/les-dispositifs-medicaux-et-les-dispositifs-medicaux-de-diagnostic-in-vitro-dmdiv
ANSM (01 July 2021). Déclarer une rupture dans la disponibilité d’un dispositif médical ou d’un dispositif médical de diagnostic in vitro indispensable. Retrieved on 21/09/2021 from https://ansm.sante.fr/vos-demarches/industriel/declarer-une-rupture-dans-la-disponibilite-dun-dispositif-medical-ou-dun-dispositif-medical-de-diagnostic-in-vitro-indispensable
ANSM (4 August 2021). Indisponibilité d’un dispositif médical : l’ANSM publie une procédure de gestion préventive pour les opérateurs du marché. Retrieved on 21/09/2021 from https://ansm.sante.fr/actualites/indisponibilite-dun-dispositif-medical-lansm-publie-une-procedure-de-gestion-preventive-pour-les-operateurs-du-marche