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Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

ISO 13485:2016 reconfirmed

Please be advised that ISO TC210 have reconfirmed ISO13485:2016 until 2030. Note that ISO 9000 QMS – fundamentals and vocabulary will be updated to ISO9000:2026 and this will have a impact on ISO13485 as a normative reference, but the core requirements of ISO 13485:2016 will remain.
Ben Kemp
October 31, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Registrar of Companies (Fees) (Amendment) Regulations 2025

The Registrar of Companies (Fees) (Amendment) Regulations 2025 These Regulations amend the Registrar of Companies (Fees) (Companies, Overseas Companies and Limited Liability Partnerships) Regulations 2012 (S.I. 2012/1907) (“the 2012 Regulations”), the Registrar of Companies (Fees) (Registrar of Overseas Entities) Regulations 2024 (“the 2024 Regulations”), the Registrar of Companies (Fees) (Limited Partnerships and Newspaper Proprietors) Regulations 2009 (S.I. 2009/2392) (“the 2009…
Ben Kemp
October 31, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Updated information for BSI clients on Periodic Safety Update Reports (PSURs)

Following legislation amendments (EU)2023/607, (EU)2024/1860 and new PMS regulations applicable in Great Britain, BSI is providing updated information on PSUR. Topics covered in this communication: BSI PSUR evaluation process and PSUR submission timelines Combined reviews of PSUR under EU regulations and UK MDR PMS requirements for Great Britain PSURs for legacy devices placed on the market under the Directives PSUR…
Ben Kemp
October 31, 2025
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ESG California List of companies – expected to report

Includes a number of the larger Diagnostic companies in the list. Although not applicable to the SMEs or even some of the larger businesses, again these businesses will find that if they’re suppliers to the bigger companies then they’ll still be asked for their emissions etc. so the bigger businesses can do their own reporting. California Releases List of More…
Ben Kemp
October 2, 2025
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New guidance and tools for GOV.UK sanctions content

Note that although IVDs are typically not themselves subject to restrictions under sanctions unless possibly considered to be dual use, or contain cryptography technology to encrypt patient data (in which case export licences are required). Some organisations offering services related to export or finance maybe restricted or be reluctant to be involved in exports to sanctioned countries. E.g. legal services…
Ben Kemp
October 2, 2025
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UK NEQAS Microbiology and Parasitology webinar on POCT

UK NEQAS is holding a six-part pan-disciplinary webinar series Quality Standards in Point of Care Testing. The second webinar will take place on 1 October 2025 and registration is now open at https://us06web.zoom.us/webinar/register/WN_a1-uMaqNThitDqJ0F-k1OA The webinar will include the following presentations – Professor Peter L. Chiodini Malaria Antigen Rapid Diagnostic Tests, what a dipstick! With apologies to "Only Fools and Horses”…
Ben Kemp
September 25, 2025
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The Customs (Tariff and Miscellaneous Amendments) (No. 3) Regulations 2025

The Customs (Tariff and Miscellaneous Amendments) (No. 3) Regulations 2024 Regulation 2 amends the definition of “the authorised use document” in regulation 32(2) of the Customs (Special Procedures and Outward Processing) (EU Exit) Regulations 2018 (S.I. 2018/1249) to refer to a new version of that document. The new version of this document removes one commodity code to align with changes…
Ben Kemp
September 22, 2025
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