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
MHRA Response to DBT Announcement on Extension of CE Marking in the UK MHRA Response to DBT Announcement on Extension of CE Marking in the UK MHRA has confirmed that the scope of... MHRA Response to DBT Announcement on Extension of CE Marking in the UK
Office for Life Sciences Bulletin – 24 July 2023 Office for Life Sciences Bulletin – 24 July 2023 The Office for Life Sciences (OLS) is a joint unit between... Office for Life Sciences Bulletin – 24 July 2023
World Trade Organisation Notifies Members of Draft Post Market Surveillance Regulations for Medical Devices World Trade Organisation Notifies Members of Draft Post Market Surveillance Regulations for Medical Devices The World Trade Organisation (WTO) has... World Trade Organisation Notifies Members of Draft Post Market Surveillance Regulations for Medical Devices
OLS Survey on HealthTech Industry – Deadline Extended OLS Survey on HealthTech Industry – Deadline Extended The Office for Life Sciences... OLS Survey on HealthTech Industry – Deadline Extended
Software and Artificial Intelligence (AI) as a Medical Device – Project Report Published Software and Artificial Intelligence (AI) as a Medical Device – Project Report Published MHRA has published a report about an... Software and Artificial Intelligence (AI) as a Medical Device – Project Report Published
EU MDR – Notified Bodies Survey on Certifications & Applications EU MDR – Notified Bodies Survey on Certifications & Applications The Commission has published the ‘Notified Bodies Survey on certifications... EU MDR – Notified Bodies Survey on Certifications & Applications