As promised by the MHRA, the Post Market Survailence Statutory Instrument 2024 No. 1368 modifying the UK MDR 2002 (as amended), has been published 16th December 2024, and there for applies for all IVD’s placed on the GB market from 16th June 2025. If you’ve not already started preparing your Quality Management systems for the update, now the time to…
Ben KempJanuary 8, 2025
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: Added SIN impact story covering support for semiconductors in Japan. Time updated: 9:44am, 16 December 2024 Public attitudes to data and AI: Tracker survey (Wave 4) Page summary: Report detailing the findings…
Ben KempJanuary 8, 2025
Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: Information about qualifying and non-qualifying goods arriving in Great Britain (England, Scotland and Wales) has been updated. Time updated: 2:00pm, 16 December 2024
Ben KempJanuary 8, 2025
The UK and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) Page summary: Business guidance, treaty information and other documents to help you understand the UK’s accession to the CPTPP. Change made: Amended page to reflect ratification of UK’s membership of CPTPP. Time updated: 12:00am, 24 December 2024 UK trade agreements in effect Page summary: Find out about trade agreements…
Ben KempJanuary 8, 2025
Marburg virus disease: origins, reservoirs, transmission and guidelines Page summary: Marburg virus is a filovirus which, along with Ebola virus, can cause a severe and often fatal viral haemorrhagic fever (VHF). Change made: Updated the epidemiology section and map. Time updated: 10:24am, 30 December 2024 Notifiable diseases: causative agents reports for 2024 Page summary: Weekly data from UK laboratories on…
Ben KempJanuary 8, 2025
COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Updated Products approved under the Medical Devices Coronavirus Test Device Approvals Amendment Regulations spreadsheet Time updated: 1:52pm, 23 December 2024 Orphan registered medicinal products Page summary: A list of authorised orphan medicinal products registered by the UK licensing authority. Change made: Removed…
Ben KempJanuary 8, 2025
Current status: Open Opened on December 28, 2024 and will close on March 8, 2025. Health Canada is proposing to amend the Food and Drug Regulations and Medical Devices Regulations to help prevent and mitigate the risk of harm to human health due to drug and medical device shortages and discontinuations. The proposed amendments: are outlined in the Regulations Amending…
Ben KempJanuary 8, 2025
Radio equipment regulations Page summary: Guidance for businesses on the Radio Equipment Regulations 2017 and Radio Equipment (Amendment) (Northern Ireland) Regulations 2024. Change made: New guide added on the Radio Equipment (Amendment) (Northern Ireland) Regulations 2024, and existing guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into…
Ben KempJanuary 8, 2025
The European Commission continues to gather evidence of the impact of IVDR implementation, especially on manufactures plans to transition devices from IVD directive to IVD Regulation, or more importantly which devices manufacturers do not intend to transition. UK manufactures or subsidiaries who place product on the EU market including Northern Ireland are strongly encouraged to respond, noting that group companies…
Ben KempJanuary 8, 2025