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Regulatory Affairs Newsletter

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

Get ready for ICS2 – Important information for traders who move goods into Northern Ireland (NI) by road and rail

Get ready for ICS2 - Important information for traders who move goods into Northern Ireland (NI) by road and rail From the extended deadline of 31 December 2025, all hauliers and carriers transporting goods into Northern Ireland by road and rail must use the Import Control System 2 (ICS2) and provide additional data not previously required. ICS2 is the EU’s new platform for submitting Safety and Security…
Ben Kemp
December 10, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI: Privacy has changed are you ready?

Privacy has changed. Are you ready? November 2025 Stay ahead in Digital Trust with One Click Closer. With ISO/IEC 27701 now published as a stand-alone standard, marking the growing maturity of privacy as a discipline, this month we focus on transforming privacy commitments into confident, practical action. Privacy can’t be an afterthought. People want clarity. Regulators want evidence. Organizations need…
Ben Kemp
December 10, 2025
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Health Canada IMDRF table of contents for medical device applications guidance

Dear Members, please see below update that Health Canada has adopted the IMDRF Table of Contents format for medical device applications. Health Canada has adopted the International Medical Device Regulators Forum table of contents format o encourage and support the global convergence of medical device applications. View article...
Ben Kemp
December 10, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The EUDAMED four first modules will be mandatory to use as from 28 May 2026

Dear Members, The European Commission published the update on the mandatory use of the first four modules of the EUDAMED database. A reminder that the modules are available for voluntary use, and members should look to input data well before the mandatory use date. The EUDAMED first four modules will be mandatory to use as from 28 May 2026 View…
Ben Kemp
December 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Radio Equipment (Amendment) (Northern Ireland) Regulations 2025

Dear members, please be advised that the below update of Northern Ireland Legislation introduces the EU  2022/30 implementing legislation on Cybersecurity requirements to the Radio Equipment Directive. Medical Devices and IVDs are exempt, however off the shelf IT equipment with radio functions are in scope, this means that such equipment including that provided with IVDs, placed on the Northern Ireland…
Ben Kemp
December 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025

Please note the below update to the UK Biocidal products regulation: The Biocidal Products (Data Protection Periods) (Amendment) Regulations 2025 These Regulations amend Article 95 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (EUR 2012/528) (“the GB Biocidal Products…
Ben Kemp
December 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Changes to Article 95 of GB Biocidal Products Regulation

Dear members, please be advised that if you are submitting data in support of a Biocides application that the data protection periods are being extended as per the below notification. Changes to Article 95 of GB Biocidal Products Regulation Regulations have been laid in Parliament to change the data protection end date in Article 95(5) to 31 December 2030. The…
Ben Kemp
December 10, 2025
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Windows 10 end of support: Potential impact on medical devices

Dear members, please see below TGA post regarding Windows 10 end of support: Potential impact on medical devices. It doesn’t take into account LTSC Enterprise licences (End of support 12 Jan 2027) or Enterprise IoT licences which have an end of support scheduled in 2032. Some medical devices could be affected by the end of support for the Microsoft Windows…
Ben Kemp
December 10, 2025
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