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Regulatory Affairs Newsletter Archive

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade (WC 28 Oct)

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 Kemp
November 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care (WC 28 Oct)

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 Kemp
November 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero (WC 28 Oct)

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 Kemp
November 1, 2024
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Is your medical software market-ready?

Sade Sobande, lead QA/RA consultant As medical devices become increasingly interconnected, their software applications must also be safe and effective when placed on the market. In this on-demand webinar, Sade Sobande, lead QA/RA consultant at Emergo by UL, provides insight into how medical device regulations, standards, and guidance are keeping pace with the proliferation of medical device software. Learn about:…
Ben Kemp
November 1, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For information: F-Gas exemptions published in EU OJ

Dear members, please review the MedTech Europe update below on the Exemptions covered by the F-Gas regulation. Please send me any feedback. This legislation will impact CE marked goods including those placed on the NI market.   Dear members, I hope you are all well. We would like to inform you that the Commission exemptions for certain F-Gas uses (Annex…
Ben Kemp
November 1, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Updates on EP resolution and MedTech Europe’s reaction

Dear members, be advised that the European Parliament voted through the attached resolution in regard to the focused evaluation of the implementation of the EU IVDR/MDR. Please find here MedTech Europe's feedback and response. There have been significant conflicting calls for the European Commission to both speed up the review, as the problems are now, but also calls not to…
Ben Kemp
November 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

IVDD Certificate Validity

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 Kemp
November 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety

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 Kemp
October 25, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 21 Oct)

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 Kemp
October 25, 2024
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