Europe - Dec 2018

Nov 5, 20181 min read

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

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