Europe - Dec 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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Europe - May 2020

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by one year EU: Continued use of lead as a thermal stabiliser in P

EU: MDR delayed to 26 May 2021

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

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