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 PVC as a base material in certain IVDs

  • EU: Amendments to the Common Technical Specifications for IVDs

  • EU: Three new and three revised guidance documents issued by the MDCG

  • EU: Joint implementation and preparedness plan for the MDR

  • EU: Publication of new list of harmonised European standards

  • Finland: National legislation drafted to support implementation of EU Regulations

  • France: Distribution agreements must be in place by 1 January 2021

  • Ireland: Guidance on applying for Certificates of Free Sale has been updated

  • Spain: PMPS to finally close in May 2020

  • UK: MHRA fees unchanged for 2020/2021

  • UK: ‘Medicines and Medical Devices Bill 2019–21’

  • UK: Help for UK companies affected by closure or scope reduction of their Notified Body

  • UK: Updated guidance explains process for determining when clinical investigation is necessary


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