The Ordinance contains several coordination, repealing, and simplification measures necessary to bring the current legislative provisions of the FPHC in line with the MDR.
Primarily, as per the Ordinance, clinical investigations (research on medical devices involving human subjects) are excluded from the FPHC general regime related to research involving human subjects. Along these lines, a new chapter is created to describe the specific provisions applicable to such clinical investigations on medical devices, in particular the conditions under which the ethical review by committees for the protection of individuals (CPP) is carried out, as well as the criminal sanctions in the event of infringements by clinical investigations' sponsors.
The definition of medical devices, accessories and the scope of application of the medical devices rules (extended to products without an intended medical purpose but which are similar to medical devices in terms of their function and risk profile - listed under Annex XVI of the MDR) now mirrors the detailed and thorough provisions of the MDR.
The National Agency for Safety of Medicines and Health Products (ANSM) is still identified as the competent authority in charge of market surveillance relating to medical devices and Annex XVI products (except for those intended exclusively for direct use by consumers or as part of a service to consumers - those being monitored by the General Directorate for Competition, Consumption and Fraud Controls, also known as DGCCRF).
The registration procedures for economic operators which are not concerned by the mandatory EUDAMED registration under the MDR (including distributors and manufacturers of custom-made medical devices) are specified in the Ordinance.
The updated FPHC provisions also provide for specific criminal and financial sanctions in case of violations of the MDR. In particular, failure to notify a serious incident, a corrective safety action, a serious risk, a falsified device, failure to register an economic operator in the EUDAMED database or to update this information and placing on the market devices which are non-compliant with general safety and performance requirements, are subject to criminal sanctions.
Finally, the Ordinance provides for transitional measures for medical devices (as well as Annex XVI products) and research on medical devices involving human subjects.
This adaptation work is still ongoing as further implementing decrees are now expected to complete the Ordinance.
