Medical devices for individual use (pursuant to Article L5212-1-1 of the Public Health Code)

Order on reconditioning pursuant to Article L5212-1-1 of the Public Health Code

Pursuant to Article L5212-1-1 of the Public Health Code, this Order lays down the conditions to which reconditioning operations are subject in order to ensure the quality and safety of use of the reconditioned device. These conditions are established by a mandatory technical standard.
Decree No 2025-247 of 17 March 2025 on the reconditioning of certain medical devices defines the rules guaranteeing the quality and safety of reconditioned medical devices after they have been put into service, as well as the rules governing coverage by the French national health insurance scheme (national social security system) and the traceability requirements for these products. This Decree was notified under the 2015/1535 procedure (2023/0135/F) on 24 March 2023.
As a reminder, Regulation (EU) 2017/745 of 5 April 2017 on medical devices does not harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales, as stated in recital 3.