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Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 31 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 31 July)

Please note this is an extract of the original bulletin. CE marking recognition for medical devices and in vitro diagnostics Page summary: The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Change made: First published. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers…
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August 11, 2023
DHSC weekly update (WC 31 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 31 July)

Please note this is an extract of the original bulletin. Government boosts use of independent sector capacity to cut NHS waits Page summary: Thirteen new community diagnostic centres are opening across the country to deliver more than 742,000 additional scans, tests and checks a year Change made: First published.  
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August 11, 2023
DSIT weekly update (WC 31 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 31 July)

Please note this is an extract of the original bulletin. 5G Innovation Regions Page summary: A £40 million fund for local and regional authorities across the UK to establish themselves as ‘5G Innovation Regions’. Change made: First published. £40 million fund launched to unlock 5G benefits across the UK Page summary: The government has launched a £40 million fund to…
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August 11, 2023
TGA publishes new guidance on manufacturer evidence for IVD medical devices Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter Archive

TGA publishes new guidance on manufacturer evidence for IVD medical devices

Following the phase out of ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, the TGA have published a guidance that helps sponsors to transition to using another form of manufacturer evidence to ensure ongoing regulatory compliance. The new guidance can be found here.
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August 11, 2023
DBT weekly update (WC 31 July) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 31 July)

Please note this is an extract of the original bulletin. Using the UKCA marking* Page summary: Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle. Change made: Updated the ‘call to action’ banner before the main body of text, to list the sectors the CE marking will continue to apply…
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August 11, 2023