Background

The shortage of medical devices has been a growing concern in Europe over the last several years. Particularly since the 26 May 2024 MDR transition deadline has passed.

Both the MDR and IVDR will shortly be amended to require that manufacturers inform stakeholders if they anticipate interruption to the supply of critical devices. Read more about the upcoming requirement here.

The National Competent Authorities are working on cohesive ways to enforce this new requirement. For example:

• Developing templates for reporting shortages
• Developing a central system for input and sharing of information
• Define “interruption of supply of a device”, “reasonably foreseeable”, and “serious harm or risk of serious harm to patients or public health”

Stay tuned for more information on when and how to report shortages throughout Europe.

Today’s Update

The French Competent Authority (ANSM) has had a process for reporting on supply disruption since 2021. On 5 July 2024, they published an updated process, which will commence as of 1 September 2024. The update is available (in French) here.

The webpage also provides the below reminder (informal translation from French to English):

Reminder of the steps in managing the unavailability of a Medical Device or IVD
Stage 1: Preventive management by the operator in conjunction with users and purchasers
As soon as a manufacturer is aware of the unavailability or risk of unavailability of a medical device or IVD, it implements, using all the means at its disposal, an appropriate action plan to alleviate the situation as best it can: quotas, increased production capacity, identification of alternative solutions, including from competitor companies, etc. At this stage, ANSM is not involved.
Stage 2: Management by the operator in conjunction with ANSM
If the actions taken do not suffice to reduce or eliminate the criticality of the situation, the manufacturer sends us a declaration of disrupter. We provide support and help identify solutions, notably in conjunction with our network of partners, in the interests of patients. In the interests of optimal management and transparency, we publish all relevant information on this disrupter.

What’s changing?

A risk analysis grid is now available, to help assess the criticality level of the supply shortage. ANSM also redesigned their flowcharts to clarify management methods. As well, the process now extends to reporting on marketing stoppages.

Those are available (in French) here.

Section 1 of the webpage includes information on the risk of disruption (supply tension), a realized disruption, or a temporary marketing suspension. Section 2 is for when marketing will fully stop.

Further, starting 1 September 2024, the declaration forms will be accessible via a simplified process, through this platform.  

Below is an example of the risk grid for risk of disruption to supply (informal translation from French to English). Click on image to enlarge.