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Regulatory Affairs Newsletter

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New International Standards on Artificial Intelligence

CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: EN ISO/IEC 22989:2023 - Information technology - Artificial intelligence - Artificial intelligence concepts and terminology (publication date: 2023-06-28) and EN ISO/IEC 23053:2023 - Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML) (publication date: 2023-06-28). These standards describe the terminology for AI and concepts of AI system…
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June 30, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA guidance update: timelines for CE marked products

The MHRA have recently published an overview of timelines for placing CE marked IVD devices on the Great Britain market. The update focuses on the transitional arrangements for CE marked IVD devices compliant with EU IVDD and EU IVDR. For better understanding, a written guidance and an infographic of the timelines for placing CE marked IVD devices on the Great…
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June 23, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 12 June)

Please note this is an extract of the original bulletin. Research Ventures Catalyst Page summary: A pilot programme that will stimulate the creation of collaborative research ventures, supported by consortia drawn from the public sector, industry and the third sector. Change made: First published. £54 million boost to develop secure and trustworthy AI research Page summary: Secretary of State for…
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June 23, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 12 June)

Please note this is an extract of the original bulletin.   Patients to benefit from new ambulance hubs and discharge lounges Page summary: The facilities will help cut urgent and emergency care waiting times for tens of thousands of patients across the country Change made: First published. Government response to the HSCC report and the Hewitt Review on integrated care…
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June 23, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 12 June)

Please note this is an extract of the original bulletin. UK Trade Tariff: duty suspensions and autonomous tariff quotas Page summary: Temporary duty suspensions and autonomous tariff quotas for importing goods into the UK. Change made: An application form and a guidance document added to the ‘Apply for a new duty suspension’ section. UK-Switzerland enhanced free trade agreement negotiations Page summary:…
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June 23, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 12 June)

Please note this is an extract of the original bulletin. Regulating medical devices in the UK Page summary: What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Change made: Published overview of timelines for placing CE marked IVDs on the Great Britain market Implementation of medical devices future…
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June 23, 2023
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