SciMed’s MedTech Horizon:
Monthly monitoring of regulatory developments across the EU, UK, US, Canada, and Australia.
Regulatory Intelligence
Each month, SciMed's team monitors guidance publications, implementing acts, enforcement signals, and compliance deadlines from the European Commission, MDCG, MHRA, FDA, Health Canada, and the TGA. This page is where that monitoring is published.
Each update covers the developments that matter to device and IVD manufacturers; what was issued, what it changes, and what manufacturers should watch for, alongside a confirmed deadlines list for the 90 days ahead. Posts are published alongside the corresponding MedTech Horizon newsletter edition.
Monitoring EU, UK, US, Canada & Australia regulatory bodies each month
Covering MDR, IVDR, MHRA, FDA, Health Canada & TGA developments
Published & circulated with MedTech Horizon every month
Regulatory Intelligence | July 2026
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.
Regulatory Intelligence | June 2026
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.
Regulatory Intelligence | May 2026
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.