Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: Removed DEU/002/2021/001 (Numed Inc) & DEU/001/2024/001 (Inspire Medical Systems, Inc.) from Open list.Added DEU/001/2024/001 (Inspire Medical Systems, Inc.) to Closed list. Time updated:…
Ben KempNovember 1, 2024
Transit newsletters – HMRC updates Page summary: Check for the latest updates about moving goods using transit and the New Computerised Transit System (NCTS). Change made: Newsletters ‘October 2024 – NCTS Phase 5: declaring National Transit movements’, ‘October 2024 – NCTS Phase 5: contact details’ and ‘October 2024 – NCTS Phase 5: pre-lodged declarations’ have been added. Time updated: 9:25am,…
Ben KempNovember 1, 2024
DSIT commercial pipeline, October 2024 Page summary: An overview of the commercial pipeline at the Department for Science, Innovation and Technology (DSIT). Change made: First published. Time updated: 8:49am, 22 October 2024 DSIT commercial pipeline Page summary: A collection of the commercial pipelines published every 6 months for the Department for Science, Innovation and Technology. Change made: Added DSIT commercial…
Ben KempNovember 1, 2024
Making Work Pay: creating a modern framework for industrial relations Page summary: We are consulting to modernise the legislative framework that underpins trade unions, seeking views on several specific measures. Change made: First published. Time updated: 12:30pm, 21 October 2024 Making Work Pay: the application of zero hours contracts measures to agency workers Page summary: The government is seeking views…
Ben KempNovember 1, 2024
Government issues rallying cry to the nation to help fix NHS Page summary: Members of the public as well as NHS staff and experts will be invited to share their experiences views and ideas for fixing the NHS Change made: First published. Time updated: 12:01am, 21 October 2024 Change NHS: help build a health service fit for the future Page…
Ben KempNovember 1, 2024
Increasing divergence in ECO Design and Energy related products legislation between GB and NI, note that this impacts Standby functions, PC, Laptops, tablets, mobiles, external power supplies and tranformers etc. This is most likely to impact off the shelf accessories used with IVD instruments. So again a reminder that NI is following the EU who have updated the requirements, and…
Ben KempNovember 1, 2024
Dear members, please be advised, that the MHRA Info page Implementation of the future regulations has been updated with a revised infographic of the timelines for placement of CE marked medical devices on the Great Britain market, which now considers the extended transition period under article 110 EU IVDR also for placing legacy IVDs on the market in Great Britain,…
Ben KempNovember 1, 2024
The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament yesterday evening is the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA). You can find the press release here.
Ben KempOctober 25, 2024
UK Science and Innovation Network impact stories Page summary: These impact stories highlight the work of the UK Science and Innovation Network (SIN) around the world. Change made: Impact story added on Technology partnerships between the UK and Central and Eastern Europe. Time updated: 11:24am, 14 October 2024 Tech Secretary welcomes foreign investment in UK data centres which will spur…
Ben KempOctober 25, 2024