United Kingdom
3 articles
Medical Device Regulatory Sandboxes: MHRA AI Airlock, FDA TEMPO, and How Innovation Programs Are Reshaping Device Approvals in 2026
A comprehensive guide to regulatory sandboxes for medical devices — MHRA AI Airlock (£3.6M expansion), FDA TEMPO pilot for digital health, EU sandbox proposals, and how manufacturers can participate in these programs to accelerate market access.
UK Medical Device Registration Cost 2026: UKRP Pricing Models, Flat Fee vs Hourly Billing, and 3-Year Cash Flow Comparison
How much does it cost to register a medical device in the UK in 2026? A buyer-side breakdown of UK Responsible Person (UKRP) service pricing — hourly billing, registration-fee-plus-annual, and flat all-inclusive fee — with worked 3-year cash flow scenarios that incorporate the new MHRA annual GMDN-category fee from April 2026.
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.