MDD to MDR Transition
Why is the modification in the regulation ( MDD to MDR Transition ) adapted? History : You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer. Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD. How do we adapt to MDR? · Gap analysis while considering additional requirements of MDR. · Refer Annexure XVII of MDR MDR focuses on the safety and performance assurance of the devices placed on the market. MDR assures that the product causes no harm to the customers. Clinical and Non-Clinical testing methods include Clinical Investigation, PMCF studies, ...