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Please note this is an extract of the original bulletin. MHRA Windsor Framework Page summary: New Guidance in accordance with the Windsor Framework Change made: First published. UK Parallel Import Licences Following Agreement of the Windsor Framework Page summary: On this page we provide information on UK Parallel Licences following the Agreement of the Windsor Framework. Change made: First published.

Please note this is an extract of the original bulletin. Regulation of devices in Northern Ireland Page summary: Information about the EU Regulations and their implementation in Northern Ireland Change made: Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health…

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…

Please note this is an extract of the original bulletin. New action to tackle ethnic and other biases in medical devices Page summary: Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices. Change made: First published. MHRA response to Equity in Medical Devices: Independent Review Page summary: The MHRA welcomes the…

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…