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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 12 Feb)

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…
admin
February 21, 2024
Membership NewsMembership News Archive

Pioneering genetic biobank to start recruiting patients on stroke prevention medicines

The pioneering Yellow Card Biobank, a pilot launched by the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England, has begun investigating a new group of medicines used to prevent strokes known as Direct Oral Anticoagulants. The Yellow Card Biobank aims to help understand how a patient’s genetic makeup can impact the safety of their medicines and forms part of…
Ben Kemp
February 21, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Eight innovative technologies selected under IDAP pilot phase

MHRA launched Innovative Devices Access Pathway (IDAP) back in September 2023 to help streamline applications for innovative medical technologies. Today, MHRA have announced that eight innovative medical device technologies are selected for the IDAP. The eight selected innovative devices are: Blood test for Alzheimer’s disease: Roche Diagnostics Ltd has developed an Amyloid Plasma Panel which could help clinicians decide if…
admin
February 14, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 29 Jan)

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…
admin
February 7, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Extension of CE mark recognition in Great Britain

On 01 August 2023, the Department for Business and Trade (DBT) announced their intention to recognise CE marking indefinitely beyond December 2024 for the 18 regulations falling under the DBT.  It does not include IVDs or medical devices. DBT have now announced that the UK Government intends to legislate the continued recognition of goods that meet the EU requirements, including…
admin
January 31, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 Jan)

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…
admin
January 31, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 Jan)

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…
admin
January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 Jan)

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…
admin
January 17, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes a new MedTech roadmap

The MHRA have published a roadmap towards the future regulatory framework for medical devices. This sets out the relevant timelines into 2025. The roadmap intends to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances. According to the timelines, MHRA intends to run stakeholder discussions on the future core regulations during the…
admin
January 9, 2024
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