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TGA Software based medical device exclusion guidance

Dear Members, TGA has posted Guidance on Software based medical device exclusions for specific uses. Software-based medical device exclusions | Therapeutic Goods Administration (TGA) TGA – Guidance - Understanding the health facility management software exclusion - Guidance on when software used for the administration or management of health processes or facilities may be excluded from our regulatory requirements. View article...…
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March 19, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Digital Markets, Competition and Consumers Act 2024 (Commencement No. 3 and Transitional Provisions) Regulations 2026

Dear members, the implementation legislation below impacts the provision of alternative dispute resolution under the Digital Markets and Competition and Consumer Protection Act 2024. The Digital Markets, Competition and Consumers Act 2024 (Commencement No. 3 and Transitional Provisions) Regulations 2026 These Regulations bring into force Chapter 4 of Part 4 and Schedules 25 to 27 of the Digital Markets, Competition…
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March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates – WC 15th March

Clinical trials for medicines: apply for approval in the UK Page summary: How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry. Change made: Updated link to guidance for IMP+device trials. Time updated: 9:00am, 9 March 2026 Clinical trials that include an in vitro diagnostic device Page summary: Guidance on…
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March 19, 2026
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Joint industry statement following EU–Switzerland agreement package

Following the recent signature of the EU–Switzerland agreement package, MedTech Europe, Swiss Medtech and SVDI have issued a joint statement welcoming the signature and highlighting the importance of updating the medical devices chapter of the Mutual Recognition Agreement (MRA) for the medical technology sector. As many of you will know, the MRA enables mutual recognition of conformity assessment procedures, allowing…
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March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates – WC 15th March

Export processed animal protein, including in mixtures and products, except for pet food to Turkey: certificate 7193 updated Page summary: Apply online to export processed animal proteins (PAP) derived from fish and poultry, including fishmeal, poultrymeal, poultry blood meal, feathermeal and compound feeds containing PAP to Turkey, but excluding finished pet food or products for human consumption. Change made: SUP…
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March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates – WC 15th March

Businesses urged to take simple steps for smoother trade with the EU Page summary: Businesses are being urged to take simple steps to prepare for the landmark EU agri-food deal, that will cut costs, slash red tape and open up opportunities for exporters and importers. Change made: First published. Time updated: 12:01am, 9 March 2026 UK-India Free Trade Agreement: impact assessment Page summary: This impact assessment sets out the potential economic, sectoral, distributional and environmental impacts…
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March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates – WC 15th March

IPO confirms continued funding for specialist IP crime unit Page summary: Three-year funding commitment alongside new industry partnership pilot. Change made: Added translation Time updated: 11:00am, 9 March 2026 Tech companies must go 'above and beyond' to protect women and girls from online abuse or face further action Page summary: Tech firms must do more to protect women and girls…
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March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates – WC 15th March

Customs, VAT and excise UK transition legislation from 1 January 2021 Page summary: This collection brings together customs, VAT and excise EU Exit legislation and notices that have the force of law applicable to UK transition. Change made: The Customs (Tariff and Miscellaneous Amendments) (No. 2) Regulations 2026 added. Time updated: 10:17am, 11 March 2026 Brexit transition helplines Page summary:…
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March 19, 2026
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Commissioner Várhelyi to open high-level event on medical devices

Commissioner Várhelyi to open high-level event on medical devices Next Monday 16 March, EU Commissioner for Health and Animal Welfare Olivér Várhelyi will open a high-level conference in Brussels on “Medical Devices: Innovation and Patient Safety”. The event, hosted by the Commission under the auspices of the Cypriot Presidency of the Council, will bring together a wide range of industry,…
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March 19, 2026
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US & EU Battery Compliance: What Manufacturers Need to Know [Webinar – March 25th, 2026]

Battery regulation is evolving rapidly across both the United States and the European Union.   In the US, more states are introducing battery stewardship laws under EPR frameworks, creating an increasingly fragmented regulatory landscape. Meanwhile, the EU Battery Regulation (2023/1542) is introducing a single framework that expands compliance to cover the entire battery lifecycle.   Join our upcoming webinar, 'Manufacturers’ Blueprint: Solving the…
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March 19, 2026
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