Eleventh Notified Body Designated Under EU IVDR Eleventh Notified Body Designated Under EU IVDR Finland-based Notified Body ‘Eurofins Electric & Electronics Finland Oy Source` has been notified... Eleventh Notified Body Designated Under EU IVDR
Launch of Innovative Devices Access Pathway Pilot Launch of Innovative Devices Access Pathway Pilot The Innovative Devices Access Pathway (IDAP) pilot, a program designed to accelerate the... Launch of Innovative Devices Access Pathway Pilot
Retained EU Law Dashboard Updated in September Retained EU Law Dashboard Updated in September A dashboard showing a list of retained EU laws (REUL) has been... Retained EU Law Dashboard Updated in September
MHRA Yellow Card Centre Launched in Northern Ireland MHRA Yellow Card Centre Launched in Northern Ireland A new regional centre to promote Yellow Card reporting has been... MHRA Yellow Card Centre Launched in Northern Ireland
Planned Meetings of MDCG and Subgroups in 2023 Updated Planned Meetings of MDCG and Subgroups in 2023 Updated The European Commission has updated the planned meeting dates of the... Planned Meetings of MDCG and Subgroups in 2023 Updated
EU MDR – Communication Survey EU MDR – Communication Survey An EU “MDR and IVDR Communication Survey” has been launched to better understand the information... EU MDR – Communication Survey
MHRA Email Update – Reporting Requirements for Medicine Shortages and Discontinuations MHRA Email Update – Reporting Requirements for Medicine Shortages and Discontinuations MHRA has updated the guidance on reporting requirements for... MHRA Email Update – Reporting Requirements for Medicine Shortages and Discontinuations
EU MDR Implementation – Overview on Applications for Designation as a Notified Body EU MDR Implementation – Overview on Applications for Designation as a Notified Body The European Commission has published an updated... EU MDR Implementation – Overview on Applications for Designation as a Notified Body
EU MDR – Flowchart on Extended Transitional Period Published EU MDR – Flowchart on Extended Transitional Period Published The Commission has published a flowchart to assist manufacturers and... EU MDR – Flowchart on Extended Transitional Period Published
Three New UK Approved Bodies for Medical Devices Three New UK Approved Bodies for Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new... Three New UK Approved Bodies for Medical Devices
MHRA – MORE User Reference Guides Update MHRA – MORE User Reference Guides Update MHRA has published an updated version of the MORE Submissions – user reference... MHRA – MORE User Reference Guides Update
Notify the MHRA About a Clinical Investigation for a Medical Device – Guidance Updated MHRA has updated their ‘Notify the MHRA about a clinical investigation for a medical device’ guidance MHRA has updated their... Notify the MHRA About a Clinical Investigation for a Medical Device – Guidance Updated
