Europe - Dec 2018

November 5, 2018

  • EU: UDI guidance documents developed by the MDCG to support implementation of MDR

  • EU: Basic guidance issued for manufacturers on implementation of the MDR and IVDR

  • EU: Public rolling plan for implementation of new EU Regulations

  • EU: Proposed updates to Common Technical Specifications for certain IVDs, especially HIV and HCV tests

  • France: Control of presentation, information or promotion for health products extended to certain medical devices

  • Serbia: Clarification on payment of annual vigilance fees for medical devices

  • Serbia: New regulations published that affect medical devices

  • UK: MHRA fees unchanged for 2018/2019

  • UK: Guidance released on products without an intended medical purpose under Regulation (EU) 2017/745

     

Click here for the full article on Global Regulatory Press.

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