MEDIMARK EUROPE

• 10 October

  10 October 2018 - About Brexit and NB, EAR and distributors located in UK

  From : EUROPEAN COMMISSION RELEASE - Brussels, 22 January 2018 - REV.1

  NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF MEDICAL DEVICES
• 12 September

  Implementation of Medical Devices EU-Regulation

  MediMark Europe has made a selection of documents which may help you to (...)
• 12 June

  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

  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

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

  The European Competent Authorities are keen to receive codified information (...)

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