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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