EU MDR Compliance Timeline (2024 to 2028): What Manufacturers Must Know Now
INTRODUCTION The EU Medical Device Regulation (EU MDR 2017/745) has completely changed how medical devices are regulated in Europe. It raises the bar on safety, clinical evidence, and post-market surveillance, and it has also introduced a complex, multi-year transition timeline. Initially, manufacturers expected to be done with the MDR transition much earlier. But delays in […]
CANADA GAZETTE AMENDS MEDICAL DEVICES REGULATIONS (ESTABLISHMENT LICENCES)
Canada, November 14, 2025, Health Canada has just proposed a major update to the Medical Devices Regulations (MDR) that could make it easier and less costly for medical device companies to do business in Canada. The proposed changes, published in Canada Gazette, Part I (Vol. 159, No. 45), are now open for public consultation until […]