MEDIMARK EUROPE

• 12 June 2018

  France Simplifies Regulations for Implantable and Class III Devices

  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.
• 4 May 2018

  Class 1 Reusable Surgical Instruments : Mandatory Conformity Assessment by a Notified Body

  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
• 15 February 2018

  New adverse event terminology to be implemented in Europe starting from 2Q 2018

  The European Competent Authorities are keen to receive codified information (...)
• 15 November 2017

  November 2017 : Team-NB Notified Bodies members’ intention to submit application to be designated against the new MDR and/or IVDR

  In the framework of the new Medical Device Regulations, you will find (...)
• 13 June 2017

  July 1st 2017: New Notification Rules in France for Class 3 and 2b implantable Medical Devices

  Modalities for the transmission of the Summary of the Characteristics of the Device Medical to ANSM

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