Meshes for Abdominal Wall Hernia Repairs: How to Combine Innovation and Security?
Seance of wednesday 15 january 2020 (Prévenir et traiter une éventration)
DOI number : 10.26299/kyfj-6p28/emem.2018.3.008
Abstract
MDR is a milestone in the field of implantable medical devices (DMI).
Before the MDR, and unlike the existing drug regulation, DMI marketing authorization, depended almost only on the CE marking.
Due to the MDR, meshes used for abdominal wall hernia repairs have been upgraded to the highest level (level III) of the scale of risks. Industrials are obliged to ensure a thorough pluri-annual security-program, for every of their product-references, which costs have not been funded to date in France. The consequences could be a decrease of innovation, a decrease of the number of French manufacturers and the loss of French autonomy/independency in the DMI sector (as in the drug sector).
Solutions, suitable for the French reimbursement system, are discussed.
Before the MDR, and unlike the existing drug regulation, DMI marketing authorization, depended almost only on the CE marking.
Due to the MDR, meshes used for abdominal wall hernia repairs have been upgraded to the highest level (level III) of the scale of risks. Industrials are obliged to ensure a thorough pluri-annual security-program, for every of their product-references, which costs have not been funded to date in France. The consequences could be a decrease of innovation, a decrease of the number of French manufacturers and the loss of French autonomy/independency in the DMI sector (as in the drug sector).
Solutions, suitable for the French reimbursement system, are discussed.