MDR 2017/745
EU Medical Device Regulation (MDR) 2017/745
The EU Medical Device Regulation (MDR) 2017/745 sets a new benchmark for medical device safety and performance within the European market. Effective as of May 26, 2021, the MDR introduces stringent requirements for manufacturers, importers, and distributors aiming to enhance patient safety and ensure the highest standards in device quality. Compliance with MDR is now essential for manufacturers who wish to market medical devices in the EU. Our team of regulatory affairs and quality assurance specialists is here to help you navigate these complex requirements and succeed in your MDR journey.
MDR 2017/745
What is the EU MDR?
The MDR 2017/745 replaces the former Medical Device Directive (MDD), setting out new rules for conformity assessment, post-market surveillance, clinical evaluation, and risk management. Under MDR, companies face increased scrutiny around product safety, clinical evidence, and device lifecycle management. For many manufacturers, this shift requires a thorough review of existing devices and compliance practices to meet the updated regulatory demands.