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HRA Now – further updates to the commercial agreements for participating NHS and HSC organisations

What: the commercial model agreements for use with participating NHS and HSC organisations have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025 Who: commercial sponsors, contract research organisations (CROs), NHS and HSC organisations Where: UK wide (England, Northern Ireland, Scotland and Wales) When: Wednesday 30 July 2025 The following suite of commercial model…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Persistent Organic Pollutants – Defra/DHSC/Trade Associations

Dear members, following a recent DEFRA/DHSC joint briefing on the UN Stockholm Convention (Persistent Organic Pollutants), please see this slide deck which maps out the process at international and national implementation. DHSC and DEFRA are particularly interested in member engagement of Socioeconomic impacts of implementation, especially with regard to what evidence members have of impact where longer transition timelines are…
Ben Kemp
August 4, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R1561: Regulation (EU) 2025/1561 of the European Parliament and of the Council of 18 July 2025 amending Regulation (EU) 2023/1542 as regards obligations of economic operators concerning battery due diligence policies

The European Commission have published the below legislation to delay the implication dates of certain requirements under the Batteries and Batteries Waste Due Diligence requirements. Regulation (EU) 2025/1561 of the European Parliament and of the Council of 18 July 2025 amending Regulation (EU) 2023/1542 as regards obligations of economic operators concerning battery due diligence policies (Text with EEA relevance) View…
Ben Kemp
August 4, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

PUBLISHED – MedTech Europe reflection paper on Sampling under IVDR

Dear Members, MedTech Europe have published the reflection paper on Notified Body Sampling of technical files under the IVDR. This is part of the work that MedTech Europe is under taking to look at reducing administrative burden as part of the review of the implementation of the IVDR. You can find the published document on MedTech Europe website here: https://www.medtecheurope.org/news-and-events/news/sampling-under-in-vitro-diagnostics-regulation-medtech-europe-proposal-for-a-more-risk-based-approach/…
Ben Kemp
August 4, 2025
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IEC 61326-2-6 Ed 4.0 2025-06 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

Dear members, The FDA yesterday announced its complete recognition of the International Electrotechnical Commission’s standard IEC 61326-2-6 Edition 4.0 2025-06. The standard applies to basic safety and essential performance of in vitro diagnostic medical electrical equipment when exposed to electromagnetic disturbances.   Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number…
Ben Kemp
August 4, 2025
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 July)

UK Emissions Trading Scheme scope expansion: waste Page summary: The UK ETS Authority is seeking views on the implementation of the expansion of the UK Emissions Trading Scheme to energy from waste and waste incineration. Change made: Interim Authority response published. Time updated: 6:16pm, 21 July 2025 Integrating greenhouse gas removals in the UK Emissions Trading Scheme Page summary: The…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 28 July)

Proposed Statement of Strategic Priorities for telecommunications, the management of radio spectrum, and postal services Page summary: We are seeking views on the proposed Statement of Strategic Priorities for telecommunications, the management of radio spectrum, and postal services. Change made: First published. Time updated: 3:30pm, 21 July 2025 OpenAI to expand UK office and work with government departments to turbocharge…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Update (WC 28 July)

Boost in support for patients with chronic fatigue syndrome or ME Page summary: Better care for patients living with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome, with plans to invest in research and offer closer to home. Change made: First published. Time updated: 12:01am, 22 July 2025 ME/CFS: the final delivery plan Page summary: The final delivery plan on myalgic encephalomyelitis/chronic fatigue…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 28 July)

Designated standards: radio equipment Page summary: Notices of publication and a consolidated list for designated standards for radio equipment. Change made: Correction made to notice of publication 0119/25. Time updated: 9:58am, 21 July 2025 Refining the law to better protect consumers Page summary: The Product Regulation and Metrology Act 2025 enables the Government to amend regulations to reflect how products…
Ben Kemp
August 4, 2025