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Regulatory Affairs Newsletter Archive

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC webinar on the Windsor Framework

DHSC have provided the following update for stakeholders: DHSC would like to invite you to a webinar at 2pm on Thursday 16 March, on the recent announcement from the Government on the significant changes to medicines in the Windsor Framework. We will be joined by colleagues from MHRA, and will be discussing: The replacement of the EMA by the MHRA…
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March 9, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter Archive

EU MDR/EU IVDR amendment approved by EU Council

On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…
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March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. MHRA Graduate Scheme Page summary: Information about the MHRA’s Graduate Scheme and how to apply. Change made: First published.   Working for MHRA Page summary: Information on how to apply for jobs, workplace benefits and skills development at the Agency. Change made: Added link to MHRA graduate Scheme.   Medical…
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March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. England Rare Diseases Action Plan to tackle health inequalities Page summary: The 2023 England Rare Diseases Action Plan goes further than ever before to support people living with rare diseases. Change made: First published.   England Rare Diseases Action Plan 2023 Page summary: The second action plan setting out how…
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March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (20 Feb)

Please note this is an extract of the original bulletin. Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Page summary: The EU Commission has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates Change made: First…
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March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Feb)

Please note this is an extract of the original bulletin. Plans to bolster patient safety and boost support for frontline staff by streamlining the system for healthcare regulators Page summary: The government will streamline the system to modernise regulatory legislation to boost patient safety and support staff Change made: First published.   Lord O’Shaughnessy to lead independent review into UK…
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March 9, 2023
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