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
Team NB Publication – Position Paper – Transfer Agreement for Surveillance of Legacy Devices Team NB Publication – Position Paper – Transfer Agreement for Surveillance of Legacy Devices Team NB has published a position paper... Team NB Publication – Position Paper – Transfer Agreement for Surveillance of Legacy Devices
Team NB Position Paper on Transitional Timelines and Notified Body Capacity for the New Medical Device Regulation Team NB Position Paper on Transitional Timelines and Notified Body Capacity for the New Medical Device Regulation Team NB has... Team NB Position Paper on Transitional Timelines and Notified Body Capacity for the New Medical Device Regulation
Closure of the AIC XML Mailbox for Submitting Adverse Incidents to Medical Devices to the MHRA Closure of the AIC XML Mailbox for Submitting Adverse Incidents to Medical Devices to the MHRA The AICXML mailbox, currently... Closure of the AIC XML Mailbox for Submitting Adverse Incidents to Medical Devices to the MHRA
MHRA Guidance – Register Medical Devices to Place on Market Updated MHRA Guidance – Register Medical Devices to Place on Market Updated The MHRA has updated their guidance on how to... MHRA Guidance – Register Medical Devices to Place on Market Updated
MHRA Medical Devices: Guidance for Manufacturers on Vigilance Updated MHRA Medical Devices: Guidance for Manufacturers on Vigilance Updated The MHRA has updated their guidance for manufacturers on vigilance which... MHRA Medical Devices: Guidance for Manufacturers on Vigilance Updated
