covid-19

Please note this is an extract of the original bulletin. Rubidium (Rb82) Generator approved as a diagnostic tool for people with heart disease Page summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagnostic tool for imaging of the heart, to evaluate blood flow and aid in…

Please note this is an extract of the original bulletin. MHRA Chief Executive Dame June Raine to step down later this year Page summary: Dame June Raine, MHRA’s Chief Executive, will be stepping down in the Autumn following five years in the role Change made: First published. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway…

Please note this is an extract of the original bulletin. Funding for game-changing tech which could destroy cancers and predict disease Page summary: Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke Change made: First published. Medical devices given exceptional use authorisations…

Please note this is an extract of the original bulletin. Regulating medical devices in the UK Page summary: What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Change made: The standard fee per application has changed to £240  

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Updated the details for LNE-GMED UK Limited, TUV SUD BABT Unlimited (0168) and Scarlet NB UK Ltd (8536) in the ‘UK approved bodies for medical…

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: The three PDFs for BSI Assurance UK Ltd have been updated. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have…

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 template for submitting Quarterly Summary Reports. Medical devices: UK approved bodies Page summary: UK approved bodies listed…

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices. Change made: Added ‘Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices’ and information about ‘future core regulations’. Regulatory…