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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…
admin
July 7, 2023
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…
admin
July 7, 2023
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…
admin
July 7, 2023
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…
admin
July 7, 2023
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