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Regulatory Affairs Newsletter Archive

Draft statutory instrument for the Windsor Framework published UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument for the Windsor Framework published

The draft statutory instrument on the Windsor Framework has been published. This will now go through a vote in the House of Commons, but is likely to be implemented into UK law. Secondary legislation will then be developed in order to action the contents of the Framework. BIVDA have requested confirmation from MHRA and DHSC on how this Framework will…
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March 24, 2023
MHRA request to engage earlier for safety issues UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA request to engage earlier for safety issues

MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety. Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD…
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March 17, 2023
MHRA weekly update (WC 6 Mar) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Advisory Group Reform Proposals Page summary: Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. Change made: First published. MHRA fees Page summary: Fees payable to the MHRA for 2022 to 2023 Change made: Added link to application form to ‘apply for Small and Medium Company…
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March 17, 2023
DHSC weekly update (WC 6 Mar) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Government to consider radical new approach to prevent life-threatening cardiovascular disease Page summary: Professor John Deanfield, CBE announced as the first ever Government Champion for Personalised Prevention Change made: First published. Minister meets leading researchers in women’s health and calls for more women working in STEM Page summary: Today (Monday…
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March 17, 2023
MDCG guidance schedule European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

MDCG guidance schedule

The MDCG have published their latest ongoing guidance update. The following IVDR-related documents are included in this list: Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date) Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023) Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2…
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March 17, 2023