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Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 03 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 03 July)

Please note this is an extract of the original bulletin. AI Council Page summary: An update on the AI Council. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects for people interested in the field of cyber security. Change made: We have added the June 2023 edition of…
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July 14, 2023
European Commission published update on EU reference labs European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

European Commission published update on EU reference labs

The European Commission has provided an update on the designation of EU reference labs. Reference labs are intended for high-risk medical devices and should be a part of the conformity assessment process. There are currently no reference labs designated for the IVDR. In July 2022, the European Commission opened applications to become a reference lab, specifically under 8 categories: Hepatitis…
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July 7, 2023
MHRA weekly update (WC 26 June) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 26 June)

Please note this is an extract of the original bulletin. Timeframe for accepting CE marked medical devices in Great Britain extended Page summary: CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023 Change made: First published. Register medical devices to place on the market Page summary: How to register your medical…
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July 7, 2023
DBT weekly update (WC 26 June) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 26 June)

Please note this is an extract of the original bulletin. Protection of Trading Interests Page summary: How UK persons’ trading interests are protected and when authorisations must be obtained to trade with countries subject to specific extraterritorial laws. Change made: First published. UK subsidy control statutory guidance Page summary: This guidance explains public authorities’ legal obligations under the UK subsidy…
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July 7, 2023
DSIT weekly update (WC 26 June) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 26 June)

Please note this is an extract of the original bulletin.   Science and tech figureheads lead government innovation charge Page summary: Startup boards meets for the first time, supporting department’s goal of making the UK a science and technology superpower by 2030. Change made: First published UK-Singapore data and tech agreements to boost trade and security Page summary: Memorandum of…
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July 7, 2023
EN ISO 25424 updated as a harmonised standard to the IVDR European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EN ISO 25424 updated as a harmonised standard to the IVDR

The European Commission has published confirmation that EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices is now harmonised to the IVDR.
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July 7, 2023
DHSC weekly update (WC 26 June) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 26 June)

Please note this is an extract of the original bulletin.   New lung cancer screening roll out to detect cancer sooner Page summary: National targeted lung cancer screening programme designed to catch cancer sooner announced Change made: First published. Health Secretary's Oral Statement on lung cancer screening Page summary: Health and Social Care Secretary Steve Barclay delivered an Oral Statement…
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July 7, 2023