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Regulatory Affairs Newsletter Archive

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For approval by 8 July: RoHS renewal requests (Batch 1)

Dear members, please see the below update on progress with EU RoHS renewals proposed by the Umbrella project. Let me have any objections to MedTech Europe Co-Signing these exemption requests by CoB  4th July. Note that if successful these will apply to Northern Ireland, however to obtain similar exemptions for GB, separate applications under GB RoHS are required and there…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 23 June)

MHRA Performance Data Page summary: Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function. Change made: Performance data published for May 2025. Time updated: 9:33am, 16 June 2025 Medical devices: examples of reportable incidents Page summary: Examples of what manufacturers must report to the MHRA under the medical device…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 23 June)

Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: The foot and mouth disease (FMD) section has been updated to provide details on action taken due to an outbreak of foot and mouth disease in Eswatini. Time updated: 4:57pm, 16 June…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 23 June)

Unprecedented boost for clinical trials under 10 Year Health Plan Page summary: Millions will take part in clinical trials under the 10 Year Health Plan which will speed up clinical research. Change made: Statements from the British Heart Foundation and Wellcome have been included. Time updated: 4:46pm, 16 June 2025 New data laws will make life easier for British people,…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 23 June)

Maps of Thames Freeport customs sites Page summary: These maps show the Freeport customs sites within the Thames Freeport. Change made: Map of ‘Customs Site No.2 Thames’ has been added. Time updated: 12:15am, 16 June 2025 Register to make an entry summary declaration in Great Britain Page summary: Use the S&S GB service if you import goods into Great Britain…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards (WC 23 June)

Measuring container bottles: product marking Page summary: Guidance for businesses on the marking of measuring container bottles, with lists of approved and inactive manufacturers’ marks. Change made: Content updated and extra information on the legislative background provided. Time updated: 11:48am, 19 June 2025 Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 23 June)

Memorandum of Understanding between the UK and Cohere on AI opportunities Page summary: Memorandum of Understanding on AI opportunities between the UK government and Cohere. Change made: First published. Time updated: 12:02pm, 16 June 2025 Cyber Growth Action Plan 2025 Page summary: Details and terms of reference for the Cyber Security Growth Action Plan Change made: First published. Time updated:…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 23 June)

Government appoints Emma Jones CBE as new Small Business Commissioner to help tackle late payments Page summary: Government appoints new Small Business Commissioner as part of efforts to boost SMEs and tackle late payments Change made: First published. Time updated: 9:12am, 17 June 2025 Notice to exporters 2025/16: updated use of special and diacritic characters on the customs declaration service…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 23 June)

Untreated blood products for the manufacture of derived products for purposes outside the feed chain for farmed animals to, or transit through, the European Union and Northern Ireland: certificate 8308 updated Page summary: Apply online for an export health certificate (EHC) to export blood products from Great Britain (England, Scotland and Wales) to the EU or move them to Northern…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 19 06 25

Ongoing digital border service issue We are continuing to experience intermittent issues with the IPAFFS system. Please note this is not a CDS issue.  If you encounter any problems or disruptions, you must contact the STORM Incident Hub - manned 24/7. Please Email: Stormincidentresponse@defra.gov.uk Before contacting Storm, please ensure: The CHED is fully submitted and visible in IPAFFS. SPS checks (as…
Ben Kemp
June 26, 2025
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