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Ben Kemp

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: changes to Annexes II and III of GB Biocidal Products Regulation

Changes to Annexes II and III of GB Biocidal Products Regulation Changes in the data requirements for active substances and biocidal products will apply from October. The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 came into force on 6 April 2024. This legislation updates some of the data requirements in Annexes II and III of…
Ben Kemp
September 12, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

RoHS Updated Delegated Acts – Annex III Exemptions 6-7

The draft delegated acts for the RoHS Annex III exemptions series 6-7, have now been sent to the European Parliament and Council for scrutiny. This applies to the EU and NI. Contents:  These draft delegated acts have been updated to take onboard some of the recommendations of MedTech Europe and the Umbrella Project, also as discussed directly with the Commission…
Ben Kemp
September 12, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Canada and the Public Health Agency of Canada’s report on red tape reduction

Health Canada and the Public Health Agency of Canada have conducted a broad review of regulations and program administration to identify outdated, inefficient or duplicate regulations that hinder economic growth and create unnecessary burden for businesses and people in Canada. View article...
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA MedTech Regs update: Working together to advance safety, access and innovation

In our September MedTech regulations blog, MHRA Head of Diagnostics and General Medical Devices Joseph Burt seeks stakeholder feedback to two surveys and looks ahead to Autumn updates about the Pre-market statutory instrument, an IVD roadmap and the next IMDRF forum Hello again. If you’re anything like me, you’ve probably wondered how the past few months have vanished so quickly!…
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK REACH: Publication of report on the use on non-animal methods

HSE publishes report on the use of non-animal methods and other alternative approaches for UK REACH registration In line with our obligation under Article 117(3) of UK REACH, HSE has published the 2022 to 2024 report on the ways registrants fulfilled their information requirements. One of the aims of UK REACH is to promote the use of alternative methods for…
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Consultation on changes to the UK designs framework – now launched!

Our consultation on changes to the UK designs framework is now live! Following our earlier Call for Views in 2022, and Design Protection Survey earlier this year, this is the final step in making the design protection system simpler, fairer, and more accessible. We want the people who use the system to help us understand what matters most to the design…
Ben Kemp
September 12, 2025
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