August was a quieter month than July, but not one to skim past. Three developments landed within weeks of each other: the EU AI Act's transparency obligations became enforceable from the 2nd, Australia's TGA opened a consultation on how much it can say publicly about a device under investigation, and Health Canada proposed moving its recognised standards list to continuous, year-round review. None of the three impose an immediate compliance burden. All three will shape how manufacturers operate for years.

July closed out a run of deadlines regulators had flagged months ago, then added one genuine surprise. The EU AI Act Omnibus is now in force, confirming the Act's revised 2027 and 2028 deadlines for MDR/IVDR-embedded AI systems. Two delegated regulations widened clinical-investigation and technical-documentation exemptions for well-established implantable devices, Switzerland's swissdamed and Australia's UDI mandate both went live, and MDCG closed a UDI-DI loophole that private-label distribution arrangements had been quietly relying on for years. Here's what actually changed in July, and what MedTech and IVD manufacturers should do about it.

July 2026 brought a wave of regulatory activity across the EU and beyond. The headline development is the formal adoption of the EU AI Act Omnibus on 29 June, which extends the compliance deadline for AI-enabled medical devices and IVDs under MDR and IVDR to August 2028. Alongside that, MDCG 2026-4 transfers responsibility for SSCP and SSP uploads in EUDAMED directly to manufacturers, and two Commission Implementing Decisions update the list of harmonised standards, including the introduction of the EU REP symbol to replace EC REP on device labels.

Elsewhere, the WET Delegated Acts entered the Official Journal, expanding clinical investigation exemptions for well-established technologies, the MHRA launched an AI regulatory sandbox covering medical devices, and Health Canada amended its MDEL import rules. Our full June Regulatory Intelligence Briefing covers every development with the practical implications for your device programme.

EUDAMED's four core modules are now mandatory, Commission Implementing Regulation 2026/977 locks in binding notified body timelines, and MHRA has opened its UK framework consultation. This month's roundup covers every confirmed development across EU, UK, US, and Australia, plus the deadlines falling within the next 90 days.

April was the busiest month for EU classification guidance since the original MDR rollout. With the 28 May EUDAMED switchover and the IVDR Class C application deadline three weeks away, here's what manufacturers should action before the rush, plus every confirmed regulatory deadline in the next 90 days.