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Regulatory Affairs Newsletter Archive

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
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

IMDRF publishes a new guidance document

The IMDRF have published a new guidance document "Principles of Labeling for Medical Devices and IVD Medical Devices" (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document…
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May 1, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 29 Apr)

FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests Page Summary: On 29 April, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised…
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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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