Category

Regulatory Affairs Newsletter Archive

MedTech Europe survey on eIFUs for IVDs (deadline: 17 May 2024) MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey on eIFUs for IVDs (deadline: 17 May 2024)

MedTech Europe are conducting a survey for Europe based users of Near-Patient Testing devices (e.g. Medical Doctors, Physicians, Nursing staff, Operators, Pharmacy staff, Emergency Room staff, Ambulance staff) on the subject of electronic instructions for use (IFU) for Near-Patient Testing devices. This survey will provide invaluable insights into the practice in the healthcare field in the EU. Why are MedTech…
admin
April 24, 2024
DHSC weekly update (WC 08 Apr) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Medical technology strategy: one year on Page summary: Achievements made since the launch of the medtech strategy and the next steps to boost the adoption of medical technology in the NHS. Change made: First published. Medical technology innovation classification framework Page summary: Outlines the aim, scope and definitions of the…
admin
April 17, 2024
DBT weekly update (WC 08 Apr) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Joint Statement on the UK-Australia Strategic Innovation Dialogue Page summary: Following the inaugural Strategic Innovation Dialogue in London, the UK and Australia have issued a Joint Statement. Change made: First published. Harmful international trade practices: guidance for business Page summary: How to identify and report harmful trade practices that affect…
admin
April 17, 2024
DSIT weekly update (WC 08 Apr) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Weights & Biases: The AI Developer Platform Page summary: Weights & Biases provides an MLOps platform to help organisations gain auditable and explainable end-to-end machine learning workflows for reproducibility and governance. Change made: First published. RAI Institute: Artificial Intelligence Impact Assessment (AIIA) Page summary: A system-level AI Impact Assessment (AIIA),…
admin
April 17, 2024
Publication of MDCG 2022-9 rev.1 Summary of safety and performance template European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Publication of MDCG 2022-9 rev.1 Summary of safety and performance template

Directorate-General for Health and Food Safety has published the first revision of MDCG 2022 – 9: “MDCG 2022-9 rev.1 – Summary of safety and performance template”.  Members are requested to provide any comments to Regulatory@bivda.org.uk by 30 April.
admin
April 17, 2024
MHRA weekly update (WC 08 Apr) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…
admin
April 17, 2024