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UK Government Updates Regulatory Affairs Newsletter

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Draft regulations for the post market surveillance of medical devices update

Last week, Health Minister Baroness Gillian Merron has announced that draft regulations for the post market surveillance of medical devices will be laid before Parliament by the end of the year. These draft regulations will place more stringent demands on manufacturers when reporting incidents to the MHRA. Higher risk devices will also be subjected to additional surveillance. More updates will…
Ben Kemp
September 24, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 16 Sept)

MHRA consultation on statutory fees – proposals on ongoing cost recovery Page summary: Consultation on proposals to update the MHRA’s statutory fees to ensure they continue to recover their costs. Change made: Following early feedback from customers and stakeholders, we have clarified some terms in the consultation document relating to Priority 2: The MHRA proposes to amend its existing Medical…
Ben Kemp
September 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Update (WC 16 Sept)

ICAI review of DHSC's aid-funded global health research and innovation: government response Page summary: The UK government response to the Independent Commission for Aid Impact’s July 2024 recommendations on DHSC’s aid-funded global health research and innovation. Change made: First published. Time updated: 12:26pm, 10 September 2024 PM: ‘Major surgery, not sticking plaster solutions' needed to rebuild NHS Page summary: The…
Ben Kemp
September 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 16 Sept)

Joint minutes of the first UK-New Zealand Environment and Climate Change Sub-Committee Page summary: A summary of the discussions from the first UK-New Zealand Environment and Climate Change Sub-Committee including key points and recommendations. Change made: First published. Time updated: 2:18pm, 9 September 2024 UK, US and Australia sign supply chain resilience pact Page summary: The United Kingdom, United States…
Ben Kemp
September 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 16 Sept)

South Korea: UK Science and Innovation Network summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in South Korea including UK SIN priorities and successes. Change made: The ‘South Korea: UK Science and Innovation Network Summary’ has been updated. Time updated: 7:26am, 11 September 2024 Data centres to be given massive boost and…
Ben Kemp
September 17, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Research and Development Relief (Information Requirements etc.) Regulations 2024

These Regulations amend the Relief for Research and Development (Content of Claim Notifications, Additional Information Requirements and Miscellaneous Amendments) Regulations 2023 to restate the information that has to be provided by a company claiming relief from corporation tax in respect of expenditure on research and development (“R&D”). The changes they make reflect significant reforms to the R&D regime made by…
Ben Kemp
September 17, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft Scottish National Adaptation Plan 3 (SNAP3) 2024-29 – consultation analysis

The below draft response from Scottish Government, maybe of interest to Scottish based members. As climate change impact increase, we will increasing need to adapt businesses to cope with the impacts. We’re already seeing climate change being a focus of business insurance, and access to finance, both in terms of business risk including supply chain risk. We’re seeing the need…
Ben Kemp
September 11, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 9 Sept)

Notify MHRA about a clinical investigation for a medical device Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated ‘In Vitro Diagnostic Medical Devices (IVDs)’ section, Time updated: 8:55am, 6 September 2024
Ben Kemp
September 11, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Updates (WC 9 Sept)

Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Notice of publication amended and consolidated list updated. Time updated: 12:05am, 6 September 2024
Ben Kemp
September 11, 2024
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