United Kingdom
12 articles
MHRA Ambient Voice Technology 2026: When an AI Scribe Is a Medical Device in Great Britain
MHRA and NHS England 2026 guidance on ambient voice technology (AVT): 9-example medical device qualification tree, Class I vs IIa, DCB0129, and UKCA strategy.
Teleflex Global Regulatory Dossier: Arrow, UroLift, FDA Data & 2025 Sale
Data-driven regulatory dossier of Teleflex (NYSE: TFX): ~440 FDA 510(k)s, multi-country registration counts, Arrow Class I recalls, and the 2025 $2.03B divestiture.
Adaptive AI Medical Devices: Why an FDA PCCP Won't Update Your Model in the EU or Japan
A cross-market analysis of AI medical device change control, comparing the US FDA PCCP, Japan's IDATEN framework, and the EU's MDR and AI Act modification rules.
Medical Device Classification Compared: FDA vs EU MDR vs UK vs IMDRF
A comparative guide to medical device risk classification across the US (FDA), EU (MDR), UK (MHRA), and IMDRF frameworks, featuring worked examples of classification divergence.
MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide
A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.
UK MHRA Device Register: 22,554 Devices, UK Manufacturing Base & Post-Brexit Registration
Analysis of the UK MHRA device register shows 22,554 registered devices. UK manufacturers hold 33.5%, IVD accounts for 37.7%, and the top 10 manufacturers hold 13.1% of registrations.
UK MHRA International Reliance Pathway: Draft Regulations 2026 Analysis
MHRA's draft Medical Devices Regulations 2026: International Reliance Pathway for US, Canada, and Australia approvals, IVD reclassification, PCCPs for AI software, and what manufacturers must prepare.
Embecta-Owen Mumford $201M Deal: Auto-Injectors and Drug Delivery
Analysis of Embecta's Owen Mumford acquisition, including deal terms, Aidaptus auto-injector technology, diabetes business diversification, and GLP-1 drug-device strategy.
UK MHRA 2026 Overhaul: CE Mark Recognition, DORS Fees and Clinical Trials
Overview of MHRA's 2026 device reforms, including CE mark recognition, DORS fees, clinical trial changes and manufacturer compliance steps for Great Britain.
Medical Device Regulatory Sandboxes: MHRA AI Airlock and FDA TEMPO
Guide to medical device regulatory sandboxes, including MHRA AI Airlock, FDA TEMPO for digital health, EU proposals, eligibility, participation, and market access benefits.
UK Medical Device Registration Cost 2026: UKRP Pricing & 3-Year Cash Flow
UK medical device registration cost guide for 2026, comparing UKRP hourly, annual, and flat-fee pricing with 3-year cash flow and MHRA fee impacts.
UK Medical Device Regulation Post-Brexit: UKCA Marking, MHRA & The Complete Guide
Navigate UK medical device regulation after Brexit — MHRA framework, UKCA vs CE marking, UK Responsible Person, Northern Ireland Protocol, and practical compliance guidance.