Navigating EU MDR 2017/745: A Complete Guide for Medical Device Compliance
WHEN DEVICES MEET RULES: MDR FOR THE REST OF US The EU Medical Device Regulation (MDR 2017/745) is the European Union’s updated and much stricter rulebook for how medical devices must be designed, tested, manufactured, and monitored. It applies to all devices used on humans, including some that do not have a medical purpose (like […]
Health Canada’s New MDL Application Guidance: What Changes for Medical Device Manufacturers in 2026
Health Canada has released a new version of its Guidance on managing applications for medical device licences (MDLs), published 21 November 2025 and coming into force on 2 February 2026. This version replaces the 2020 “Management of Applications for Medical Device Licences” guidance and will apply to all MDL applications and reconsideration requests that are […]