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Animal and Plant Health Agency Updates – WC 19th January

African swine fever in pigs and wild boars in Europe Page summary: Updated outbreak assessment for African swine fever in wild boar and domestic pigs in Europe. Change made: Added January update for outbreak assessment for African swine fever in Europe. Time updated: 8:07am, 12 January 2026 Find a professional to certify export health certificates Page summary: A list of…
Ben Kemp
January 23, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates – WC 19th January

Stronger parental leave rights to give millions of working families the “security they deserve” Page summary: New day one rights to parental leave set to enter force from April. Change made: First published. Time updated: 10:30pm, 11 January 2026 Employment Rights Act 2025: factsheets Page summary: Further details on the measures included within the Employment Rights Act 2025. Change made:…
Ben Kemp
January 23, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates – WC 19th January

Impact statement: 10 Year Health Plan for England Page summary: The impact statement presents the impacts of the 10 Year Health Plan for England. Change made: First published. Time updated: 4:05pm, 12 January 2026 10 Year Health Plan for England Page summary: Information relating to the 10 Year Health Plan, published on 3 July 2025. Change made: Added ‘Impact statement:…
Ben Kemp
January 23, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – WC 19th January

Notices made under The Customs (Import Duty) (EU Exit) Regulations 2018 Page summary: Notices made under The Customs (Import Duty) (EU Exit) Regulations 2018 which have the force of law. Change made: The ‘Notice made under Regulation 89(5A) of The Customs (Import Duty) (EU Exit) Regulations 2018’ has been updated for conditions of authorisation that apply where declared goods are,…
Ben Kemp
January 23, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates – WC 19th January

Clinical trials that include an in vitro diagnostic device Page summary: Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device. Change made: Clarified documentation requirements where the device is not UKCA or CE marked, and the health institution exemption does not apply. Created publication ‘Figure 1. Application process for clinical trials…
Ben Kemp
January 23, 2026
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MHRA webinar: Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices

The MHRA are hosting a webinar on Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices on Tuesday 3rd February from 2pm - 3pm. During this webinar the MHRA will present guidance and advice to sponsors who are submitting clinical trials with in vitro Diagnostic (IVD) devices. The webinar will be presented in sections including: Clinical Trials with IVDs The…
Ben Kemp
January 20, 2026
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Less than three weeks to go until BIVDA’s Regulatory Affairs Seminar

There are less than 3 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham and just a few tickets are now remaining. We are pleased to announce that Kim Young, Regional Engagement Director, RAPs will present a session on The Future of Regulatory Affairs. This year's theme is 'Think Locally, Act Globally', dedicating a day…
Ben Kemp
January 19, 2026
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For review by 21 January: Weekly ECHA Substance Evaluations

Dear members, please see below list of chemicals flagged as under review for EU CLP by ECHA. MedTech Europe have highlighted the chemicals in yellow as potentially being found in MD/IVDs. Please let me know at regulatory@bivda.org.uk if any of these impact your products. CLP Intention to harmonise classification and labelling – link here:   Pyroxsulam (EC -, CAS 422556-08-9) Proposal…
Ben Kemp
January 15, 2026
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Biocides: GB active substance renewal submission deadlines

Upcoming GB active substance renewal submission deadlines Apply for active substance renewal by the relevant deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active…
Ben Kemp
January 15, 2026