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Regulatory Affairs Newsletter Archive

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

MHRA weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. Change made: Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical…
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May 29, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Government's trailblazing Institute for AI Safety to open doors in San Francisco Page summary: Technology Secretary Michelle Donelan announces first AI Safety Institute overseas office in San Francisco. Change made: First published. New independent Institute to steer UK semiconductor innovation and support semiconductor strategy Page summary: UK Semiconductor Institute announced…
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May 29, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Smarter regulation and the regulatory landscape Page summary: Call for evidence on what works and what could be improved across the landscape of UK regulators. Change made: Consultation outcome updated. Conformity assessment testing under mutual recognition or free trade agreements Page summary: When you can use a designated UK-based conformity…
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May 29, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 20 May)

FDA Webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances The U.S. Food and Drug Administration (FDA) is announcing a webinar to discuss draft guidances: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,when finalized, will describe the FDA’s enforcement policy for certain laboratory…
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May 29, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes draft policy statement on International recognition of medical devices

The MHRA have published a statement of policy intent for recognition of approvals of medical devices from international regulators by the UK. This statement of policy intent is intended to inform partners of the MHRA’s direction of travel.  The legislation will come into being at the same time as the future core regulations – anticipated to be late in 2024…
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May 22, 2024
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