Pilot Phase : Application of EU Regulation No. 2017/745

ANSM is implementing a “pilot phase” which will simulate the new organization imposed by EU Regulation No. 2017/745.

It thus prepares the entry into application of the regulations for the clinical investigation part of the Medical Devices which will impose new working methods for the competent authorities and the Ethics Committees of States Members.

Its entry into force will take place on May 26, 2020.
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