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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

European Commission publishes a proposal amending the EU MDR and EU IVDR

A proposal for amending Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) has been published by the European Commission (EC) on 23 January. The European Commission propose a gradual roll-out of the European database on medical devices (EUDAMED), obligations in case of supply interruption, and transitional provisions for certain in vitro diagnostic medical devices (IVDs). This proposal includes:…
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January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 Jan)

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 template for submitting Quarterly Summary Reports. Medical devices: UK approved bodies Page summary: UK approved bodies listed…
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January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance Page summary: The agreement between the government and the Association of British Insurers (ABI) on the use of genetic test results in underwriting insurance policies. Change made: First published. Code on Genetic Testing and Insurance: annual report 2023 Page summary: Annual report on agreement…
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January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. AI Safety Institute: overview Page summary: Find out about the AI Safety Institute. Change made: AI Safety Institute page added. Regulatory Horizons Council: Closing the Gap Series overview Page summary: RHC’s ‘Closing the Gap’ Series which aims to provide actionable insights and foster collaboration on solutions to address regulatory challenges.…
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January 24, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Overseas business risk for Slovenia Page summary: Information on key security and political risks which UK businesses may face when operating in Slovenia. Change made: Information has been updated to provide the latest data, issued by the end of the 2023. UK takes action to boost supply chain resilience for…
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January 24, 2024