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UK Government Updates Regulatory Affairs Newsletter Archive

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

DSIT weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Spain: UK Science and Innovation Network Country Snapshot Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in Spain including UK SIN priorities and successes. Change made: Summary fully reviewed and updated, Regulations: consumer connectable product security Page summary: Guidance for manufacturers, importers and…
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May 1, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. REUL (Revocation and Reform) Act 2023 statutory instruments Page summary: On this page you will find the complete list of statutory instruments (SIs) which will be laid under the REUL (Revocation and Reform) Act 2023. Change made: The Health Claims (Revocation) Regulations 2024 SI added to the page under the…
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May 1, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 Apr)

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: Added: LNE-GMED UK Limited in-vitro medical devices scope. LNE-GMED UK Limited active implantable medical devices scope Notify MHRA about a clinical investigation for a medical…
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May 1, 2024
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
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