The MHRA have released a Call for Evidence regarding the regulation of AI in healthcare. This evidence will then inform the recommendations of the National Commission into the Regulation of AI in Healthcare. The Commission is a body which brings together experts from technology, healthcare, law, patient groups, the public, government, and the NHS. The MHRA is particularly keen to…
Ben KempJanuary 6, 2026
Tell HMRC about insolvency for Plastic Packaging Tax Page summary: How to report to HMRC if an organisation becomes insolvent for Plastic Packaging Tax purposes, send any final returns and deregister. Change made: Updated the guidance to replace ‘insolvency practitioner’ with a list of roles who can submit the online form. Updated to include that you can use the online…
Ben KempDecember 22, 2025
This impacts exports of devices that can be considered ‘dual use’ i.e. could be used for military purposes, such as the creation of chemical or biological weapons. Notice to exporters 2025/33: open general export licences (OGELs) updated The Export Control Joint Unit (ECJU) has updated 8 OGELs. Please see link for details. ECJU's website can be found on GOV.UK
Ben KempDecember 22, 2025
Dear members, Remember that NI is following the EU Radio Equipment Directive (RED) including the new cybersecurity requirements that apply to off the shelf equipment, but IVDs and MDs themselves are exempt. RED applies to any devices with wireless capability including Bluetooth, WiFI, Cellular or Near Field Communication such as RFID reading. Radio equipment regulations Page summary: Guidance for businesses…
Ben KempDecember 22, 2025
Strengthening collaboration between the MHRA and the Department of Health Northern Ireland Page summary: The MHRA and Northern Ireland partners are working together to support innovation, enhance patient safety and ensure people in Northern Ireland benefit from world-class regulation. Change made: First published. Time updated: 11:24am, 9 December 2025 Complaints procedure Page summary: How to make a complaint about a…
Ben KempDecember 22, 2025
Extended CE marking recognition for Ecodesign regulations Page summary: We’re seeking views on a proposal to extend recognition of CE marking for ecodesign regulations so that it applies to new measures made under ESPR. Change made: First published. Time updated: 12:00pm, 9 December 2025 AI to accelerate national renewal and growth as Google DeepMind backs UK tech and science sectors…
Ben KempDecember 22, 2025
SaBTO hepatitis E virus (HEV) screening review and recommendations Page summary: Review of UK blood donor screening for hepatitis E virus (HEV), assessing current methods, risks and options to reduce transfusion-related HEV transmission. Change made: First published. Time updated: 10:41am, 8 December 2025 SaBTO reports and guidance documents Page summary: Reports published by the advisory committee on the Safety of…
Ben KempDecember 22, 2025
Packaging waste: apply for registration and accreditation as a reprocessor or exporter Page summary: How to apply for mandatory registration and voluntary accreditation as a reprocessor or exporter of packaging waste – includes how to comply with requirements and technical information. Change made: If you’re adding an overseas site to an accreditation during the year, you can only submit the…
Ben KempDecember 22, 2025