Microplastics – Publication of Commission Regulation 2023/2055 in OJEU Microplastics – Publication of Commission Regulation 2023/2055 in OJEU The Commission Regulation (EU) 2023/2055 of 25 September 2023... Microplastics – Publication of Commission Regulation 2023/2055 in OJEU
EUDAMED – Production Release 2.12 EUDAMED – Production Release 2.12 EUDAMED is the IT system developed by the European Commission to implement Regulation... EUDAMED – Production Release 2.12
MedTech Europe – Open Letter to Health Commissioner on Structural Reforms of Regulatory Frameworks MedTech Europe – Open Letter to Health Commissioner on Structural Reforms of Regulatory Frameworks MedTech Europe together with 34 of... MedTech Europe – Open Letter to Health Commissioner on Structural Reforms of Regulatory Frameworks
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
