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

MHRA publishes AI Strategy

On 30 April, the MHRA published its strategy for artificial intelligence (AI). This sets out the MHRA's approach to AI as a regulator of AI products, and also the use of AI more broadly across the agency. This strategy is based on 5 principles encompassing safety, security and robustness; appropriate transparency and explainability; fairness, accountability and governance; and contestability and…
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May 1, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA designates new UK Approved Body IVD devices and active implantable medical devices

The MHRA have increased their capacity to process conformity assessments for active implantable medical devices and IVD devices with the addition of LNE-GMED UK Limited to their existing list of UK Approved Bodies. Approved bodies are organisations which the MHRA have designated to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations…
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April 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 Apr)

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…
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April 24, 2024
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…
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April 17, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Apr)

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.
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April 10, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 25 Mar)

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…
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April 3, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 18 Mar)

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…
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March 27, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 11 Mar)

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…
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March 21, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 04 Mar)

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…
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March 12, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 26 Feb)

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…
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March 6, 2024
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