MDR 2017 Made Simple: Chapter IX – Recall, Suspension & License Cancellation (Part 9 of 12)
MDR 2017 Made Simple: Chapter IX – Recall, Suspension & License Cancellation (Part 9 of 12) By Ankur K. Khare – Biomedical Engineer | AI Ethics & Medical Innovation Welcome to Part 9! Having understood post-market surveillance in Part 8, we now tackle the critical Chapter IX provisions on Sale of Medical Devices , which includes Rule 89 (Recall) and the newly inserted Rule 43A (Suspension and Cancellation of Licenses) —the regulatory mechanisms that protect public health when devices fail to meet standards. Why Recall & License Actions Matter These provisions form the enforcement backbone of MDR 2017, enabling: · Swift removal of unsafe devices from the market · Accountability for manufacturers and importers · Public health protection through regulatory intervention · ...