The New Roadmap dedicated to medical devices for the period 2025-2027
The new roadmap dedicated to medical devices for the period 2025-2027 has been drawn up in response to increasing supply tensions and shortages of these products, a phenomenon that has become more acute since the health crisis linked to COVID-19. Unlike medicines, there is no equivalent list of medical devices of major therapeutic interest, mainly because of the much higher number of references and the diversity of the sector. This roadmap is based on four major areas of work:
๐น Area 1 - Identifying and Monitoring Situations at Risk of Tensions/Ruptures
This area aims to gain a better understanding of the risk factors associated with shortages and to measure their consequences for patients and the organisation of care.
- Mapping situations at risk of tensions or shortages within healthcare establishments: The aim is to provide healthcare establishments with tools to identify their supply vulnerabilities according to their activity, based in particular on methods such as the P.I.E.U. method. A database combining the benchmarks already in place in some hospitals will be created to help others.
- Measuring the impact of disruptions and tensions on the quality of patient care: A retrospective study will be carried out based on material vigilance data, and the feasibility of a prospective study will be studied to assess the consequences of disruptions on patient care in hospitals and on the organisation of care.
๐น Area 2 - Long-term Prevention of Risk Situations
The aim of this area is to raise awareness of the risk of shortages and to implement measures to secure supplies in the medium and long term.
- Optimising use in the medium/long term: This includes promoting measures for the proper use of medical devices by disseminating information from assessments carried out by health agencies and learned societies. It also involves facilitating the implementation of alternative solutions in the event of shortages, in particular by training users.
- Securing supply in the medium/long term:
- Industrial response: relocation and measures to secure supplies: The aim is to reduce dependence on imports by identifying strategic DMs and industrial vulnerabilities in order to encourage the relocation of their production in France. This approach will be based on a methodology similar to that used for medicines (MSIS). The France Relance and France 2030 programmes support these efforts.
- Procurement in healthcare establishments: Continue work on purchasing and logistics procedures: this involves improving purchasing practices by taking greater account of the risks of shortages, strengthening supplier sourcing and developing purchasing information systems to anticipate tensions by exploiting weak signals.
- Pricing: Ensuring the sustainability and diversity of the supply: The aim is to take better account of the risks of shortages in the pricing of medical devices covered by the health insurance system, particularly for products treating a minority of patients or those with no therapeutic alternative, in order to maintain a diversified supply and encourage relocation.
๐น Area 3 - Anticipate Short-term Risk Situations
This priority aims to implement measures to anticipate the risks of tensions identified upstream or foreseeable, whether they are linked to external causes (epidemics) or to supply interruptions of industrial origin.
- Securing the supply of "triple epidemic" medical devices (seasonality): This involves stepping up monitoring of the availability of medical devices that are particularly used during influenza, bronchiolitis or COVID-19 epidemics, and coordinating the actions needed to secure their supply. Annual feedback will be provided.
- Implement the information obligations arising from the European regulation on medical devices and pursue European or international actions: This area aims to exploit the information on supply interruptions that manufacturers must now declare under European Regulation (EU) 2017/745. It also involves encouraging initiatives similar to those existing for medicinal products at European level and exchanging information with other agencies such as the FDA.
๐น Area 4 - In the Event of a Disruption: Optimising the Management of the Situation
Despite prevention efforts, this axis aims to facilitate the management of disruption situations by players on the ground by structuring information exchanges and identifying therapeutic alternatives.
- Structuring the exchange of information between stakeholders via an information system: A dedicated national information system will be developed to facilitate the transmission of information between local and regional players in order to identify and qualify signals of tension. It will also be used to share management measures and available alternatives, in conjunction with ANSM and OMEDIT.
- Identifying therapeutic alternatives: The aim is to structure the exchange of information between users and learned societies in order to identify and propose alternatives to medical devices in short supply. This information will be shared via the national information system. Feedback will also be provided on the alternatives implemented.
โก A Collaborative Effort for Health Sovereignty
This roadmap requires the involvement of all stakeholders to ensure that patients receive the best possible care. It must be adaptable to new developments, and may be supplemented by new measures identified by stakeholders. The government sees this approach as a public health issue and a key element in France's health sovereignty.