Decision of the Council of State: The RCD decree concerning the need to send to ANSM, the French NCA, a summary of the characteristics for Class 2b implantable and 3 devices, has no legal basis and can only be canceled.
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Decision of the Council of State: The RCD decree concerning the need to send to ANSM, the French NCA, a summary of the characteristics for Class 2b implantable and 3 devices, has no legal basis and can only be canceled.
The article 52 ( 7) of the new EU Medical Device Regulation 2017/745 requests the involvement of notified bodies for Class 1 Reusable Surgical Instruments.
The involvement of a NB was only mandatory under the current MD Directive 93/42/EEC for Class 1 sterile and Class 1 with a measuring function.
For Class 1 Reusable Surgical Instruments, the NB will deliver a CE Certificate for the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use
The European Competent Authorities are keen to receive codified information (...)
In the framework of the new Medical Device Regulations, you will find (...)
Modalities for the transmission of the Summary of the Characteristics of the Device Medical to ANSM
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